Terms and Conditions

Terms of contract

Article 1 Validity of the conditions
1. The deliveries, services and offers of the seller shall be made exclusively on the basis of these terms and conditions. These shall therefore also apply to all future business relations, even if they are not expressly agreed again. These terms and conditions shall be deemed accepted at the latest upon acceptance of the goods or services. A counter-confirmation of the buyer with reference to his business or purchasing conditions is hereby contradicted.
2. Deviations from these terms and conditions are only effective if the seller confirms them in writing.
3. The written form is required for all legal declarations. The simple electronic form (§ 127 III BGB) does not replace the written form. The qualified electronic form (§ 126 a BGB) is required in this respect.
Article 2 Offer and conclusion of contract

1. The offers of the seller are subject to change and non-binding. Declarations of acceptance and all orders must be confirmed by the seller in writing or by telex in order to be legally effective. The same applies to supplements, amendments or subsidiary agreements.

2. Drawings, illustrations, dimensions, weights or other performance data are only binding if this is expressly agreed in writing.

Article 3 Prices
The prices of the Seller’s offers and price lists are quoted unpacked in EURO excluding VAT and freight ex works Aachen. The prices valid on the day of delivery shall be charged.
Article 4 Delivery and performance time
1. The dates and deadlines stated by the seller are non-binding, unless expressly agreed otherwise in writing.
2. The Seller shall not be responsible for delays in delivery and performance due to force majeure and due to events that make delivery significantly more difficult or impossible for the Seller – this also includes difficulties in procuring materials that occur subsequently, operational disruptions, strikes, lockouts, lack of personnel, lack of means of transport, official orders, etc., even if they occur at the Seller’s suppliers or their sub-suppliers – even in the case of bindingly agreed deadlines and dates. They entitle the seller to postpone the delivery or service for the duration of the hindrance plus a reasonable start-up time or to withdraw from the contract in whole or in part due to the part not yet fulfilled.
3. If the impediment lasts longer than three months, the buyer is entitled, after setting a reasonable grace period, to withdraw from the contract with regard to the part not yet fulfilled.
4. Insofar as the Seller is responsible for the non-compliance with bindingly agreed deadlines and dates or is in default, the Buyer shall be entitled to compensation for default in the amount of 1% for each full week of default, but in total not more than up to 10% of the deliveries and services affected by the default. Any further claims are excluded unless the delay is due to at least gross negligence on the part of the seller.
Article 5 Custom-made products
The charge for custom-made items is based on the cost price. Specially made items cannot be taken back. The cancellation of orders for custom-made items is only possible with the express written consent of the seller. The seller is not obliged to check existing industrial property rights on samples, drawings or other documents provided for special production. The responsibility for this lies solely with the ordering party. If the seller suffers disadvantages as a result of infringing the property rights of third parties in the case of custom-made products on behalf of the buyer, the seller may demand compensation from the buyer for the damage incurred.
Article 6 Shipping / Transfer of risk
The risk shall pass to the buyer as soon as the consignment has been handed over to the person carrying out the transport or has left the seller’s warehouse for the purpose of dispatch. If dispatch becomes impossible through no fault of the seller, the risk shall pass to the buyer upon notification of readiness for dispatch. The seller is entitled to insure the consignment against breakage, transport and fire damage at the buyer’s expense, unless the buyer expressly rejects this insurance.
Article 7 Warranty
1. The seller warrants that the products are free from manufacturing and material defects. The warranty period is 24 months and applies only to parts. Parts subject to wear and tear, labour and travel time, costs of transport and all other costs shall not be borne by the seller.
2. The warranty period begins with the transfer of risk.
3. The buyer is obliged to check the received goods immediately upon receipt for transport damage and any other defects, to note these immediately on the delivery note and to notify the seller.
4. In the event of notification by the Buyer that the Products do not conform to the warranty, the Seller may, at its option, require that
a) the defective part be sent to the buyer for repair and subsequent return;
b) the Buyer hold the defective part ready and a service technician of the Seller be sent to the Buyer to carry out the repair.
5. If the rectification of defects fails after a reasonable period of time, the buyer may, at his discretion, demand a reduction of the remuneration or rescission of the contract.
6. Liability for normal wear and tear is excluded.
7. Only the direct purchaser is entitled to warranty claims against the seller and these are not assignable.
Article 8 Retention of title
1. The seller retains ownership of the delivered goods until the purchase price has been paid in full and all other claims arising from the existing business relationship with the buyer have been settled.
2. The reserved goods may not be pledged, transferred by way of security or otherwise encumbered with the rights of third parties. The buyer is only entitled to resell the goods and to combine them with other movable goods within the scope of his ordinary business operations. The Buyer shall ensure that the Seller’s retention of title remains in force as far as possible and shall assign the purchase price claim of the – possibly processed – item against its customers to the Seller in full already now. The seller hereby accepts the assignment. The buyer shall name the purchasers upon request.
3. At the buyer’s request, the seller shall release security interests insofar as the security value exceeds the claims to be secured by more than 10% and the security interest is divisible.
Article 9 Payment
1. Unless otherwise agreed, the Seller’s invoices are payable 14 days after invoicing without deduction. Repair invoices are payable immediately and without deductions.
2. The seller shall be entitled to set off payments against the buyer’s older debts first, despite the buyer’s provisions to the contrary. If costs and interest have already been incurred, the seller shall be entitled to set off the payment first against the costs, then against the interest and finally against the main performance.
3. A payment shall only be deemed to have been made when the seller can dispose of the amount. In the case of cheques, payment shall only be deemed to have been made when the cheque is cashed.
4. If the Buyer is in default, the Seller shall be entitled to charge interest from the relevant date at the interest rate charged by commercial banks for open overdrafts plus the statutory value added tax, but in any case 8% interest above the respective base rate, pursuant to § 288 II BGB.
Article 10 Advance payment and security
If, after conclusion of the contract, there is a significant deterioration in the financial circumstances of the buyer or if reasonable doubts arise as to the buyer’s willingness to pay, the seller shall be entitled to demand, at his discretion, advance payments or the provision of security for his deliveries.
Article 11 Limitation of liability
Claims for damages against the Seller as well as against its vicarious agents or persons employed in the performance of its obligations, insofar as they go beyond § 4 No. 4 of these Terms and Conditions of Business, are excluded, insofar as no intentional or grossly negligent action is involved.
Article 12 Default of acceptance
In the event of a delay in acceptance of more than one month after notification of readiness for dispatch, the Seller may charge storage fees amounting to 1% of the invoice amount for each month or part thereof.
Article 13 Return of goods
1. Any return of goods requires the prior written consent of the seller. The calculated equivalent value minus the processing costs of at least 40% and any revision costs incurred shall be credited. The return shall be free of charge for the seller. Custom-made products, remakes, discontinued models and items that are not listed in the seller’s sales documents are generally excluded from return.
2. The seller as well as the buyer/customer are obliged to note and store the serial number or batch number of the product, the name and address of the next buyer/customer in the chain, stating the reason for return and the date of the complaint, irrespective of whether an approval is granted. The complaint shall be forwarded to the seller and manufacturer without delay.
Article 14 Take-back / disposal obligation
The commercial customer assumes the obligation to handle and dispose of the delivered goods properly at his own expense after termination of use in accordance with the statutory provisions – in particular in accordance with §§ 11 and 12 ElektroG. Furthermore, the commercial customer expressly releases the seller from the obligations pursuant to § 10 para. 2 ElektroG (manufacturer’s obligation to take back electrical and electronic equipment) and the claims of third parties in connection therewith. The Seller’s claim to takeover/release by the Buyer shall not become statute-barred before the expiry of two years after the final termination of use and the written notification to the Seller. At the express request of the buyer/customer, the seller shall organise the take-back and recycling/disposal of such equipment, insofar as it is distributed by the seller, against reimbursement of the costs incurred.
Article 15 Data storage
1. The buyer/customer agrees that his data relevant for the fulfilment of the contract will be stored by the seller.
2. According to DIN EN ISO 13485 clause 7.5.3, complete traceability of all delivered products must be guaranteed. The buyer/customer as well as the seller undertake to comply with this regulation.
3. The buyer/customer shall give his full name and address to the seller.
4. The buyer/customer undertakes to ensure complete traceability in the event of resale or any transfer, whether against payment or free of charge, within or outside an EU/EEA member state. Each time a product is handed over, the buyer/customer is obliged to assign the serial number or batch number of the products handed over to the full name and address of his buyer/customer and to retain this data at least for the duration of the service life of the medical device as determined by the seller and at the same time the manufacturer. However, the obligation to retain the data shall be at least 10 years from the date of product release. The records must remain legible, easily recognisable and retrievable. The records made by the buyer/customer must be made available to the seller at any time upon request.
5. The buyer/customer undertakes to ensure that, in the event of a transfer against payment or free of charge, within and outside the EU/EEA member states, his buyer/customer also complies with DIN EN ISO 13485 and that traceability is guaranteed. This buyer/customer must also oblige his further buyer/customer to guarantee complete traceability. This obligation applies to every other buyer/customer in the chain.
6. Should the buyer/customer fail to comply with the obligation imposed on him by DIN EN ISO 13485 Clause 7.5.3 and should the seller therefore suffer disadvantages, in particular in the event of a recall, the buyer/customer shall bear all additional costs incurred due to the failure to comply with this obligation. Should additional costs arise in the event of a recall due to non-compliance with DIN EN ISO 13485 by any buyer/customer in the chain, the buyer/customer of the seller and at the same time manufacturer shall bear all additional costs incurred by the seller and at the same time manufacturer due to the non-compliance. The manufacturer shall in any case be exempted from additional costs due to non-compliance with full traceability. The buyer/customer of the manufacturer shall have recourse against his buyer/customer and the latter again against his buyer/customer until the causer in the chain ultimately bears the damage.
Article 16 Quality assurance
Each buyer/customer authorised by the seller who has signed the “Quality Agreement for the Distribution of Medical Devices and Products for In Vitro Diagnostics” has undertaken with his authorisation to observe the guidelines and laws for placing medical devices and products for in vitro diagnostics as well as general laboratory equipment on the market. The corresponding concretisation of the respective directives and laws are published on the homepage www.betachek-europe.com. They are part of the General Terms and Conditions.
The buyer/customer irrevocably accepts these upon acceptance of the products. Any contradictory terms and conditions of purchase of the buyer/customer are excluded. The corresponding delivery notes contain a reference to these General Terms and Conditions of Business, which the buyer/customer hereby also expressly recognises as an integral part of the contract.
The buyer/customer also acknowledges the “Quality Agreement for the Distribution of Medical Devices and Products for In Vitro Diagnostics” published on www.betachek-europe.com. This is the subject of the contract in its current form.
Article 17 Applicable law, jurisdiction, partial invalidity
1. These terms and conditions and the entire legal relationship between the seller and the buyer shall be governed by the laws of the Federal Republic of Germany.
2. To the extent permitted by law, it is agreed that all disputes arising directly or indirectly from this contractual relationship – both nationally and internationally – shall be subject to the jurisdiction of the Aachen District Court.
3. Should a provision in these terms and conditions or a provision within the scope of other agreements be or become invalid, this shall not affect the validity of all other provisions or agreements.

Supplementary Terms and Conditions of the Betachek Online Shop

1. General
These supplementary contractual terms and conditions apply to all sales of goods by Betachek GmbH, Am Dorbach 12, 52076 Aachen (hereinafter: Betachek) to end consumers via this online shop.
2. Conclusion of contract and payment
The presentation of products in the Betachek online shop does not constitute a binding offer to conclude a contract. Rather, product presentations are intended to enable the end consumer to obtain information about the products before concluding a purchase offer to Betachek. Only when the end consumer places an order in the Betachek online shop by clicking the button “order with costs”, the order is sent to Betachek as a binding offer. The end consumer will immediately receive an order receipt confirmation by e-mail. This order confirmation does not constitute an acceptance of the offer. When the contract with Betachek is concluded depends on the payment method chosen by the end consumer:
Payment methods:
Payment can be made with the following payment methods (when available on the website): PayPal, instant bank transfer or prepayment.
Paypal: PayPal offers the end consumer simple, fast and secure payment. The data is encrypted and thus transmitted securely. PayPal is TÜV-certified and thus fulfils all the strict conditions and requirements that the TÜV places on a secure online payment system. The bank details or credit card number are securely stored at PayPal and protected by the SSL protocol and the 128-bit key. During the ordering process, the end consumer is redirected to the website of the online provider PayPal. There, payment data can be entered and the payment instruction to PayPal can be confirmed. After submitting the order in the shop, Betachek asks PayPal to initiate the payment transaction and thereby accepts the offer. A payment service provider also acts for Betachek when payment is made via PayPal.
Instant bank transfer: With the TÜV-certified payment system “Sofort” you can pay easily and securely with your usual online banking data thanks to PIN & TAN, without registration. You can make the transfer immediately after completing your order. You no longer need to go to your bank’s website. Sofort uses the secure payment form to automatically enter a transfer into the consumer’s online banking account in real time. With Sofort-Überweisung, you then instruct your bank to execute a transfer. All you need is your online banking account (PIN and TAN). By placing the order and selecting the payment method Sofort, the end consumer issues a direct debit mandate to a service provider commissioned by Betachek to process the payment transaction. The service provider collects the invoice amount directly from the end consumer’s bank account. The service provider shall inform the end user of the date of the debit from the account after receipt of the order by Betachek (so-called pre-notification). This concludes the contract with Betachek.
Prepayment: Furthermore, the invoice amount can also be transferred by bank transfer to the account stated below, stating the order number in the reason for payment:
Sparkasse Bank, IBAN: DE31 3905 0000 1073 5450 04, BIC: AACSDE33xxx
The contract is concluded as soon as Betachek requests payment from the end consumer with reference to Betachek’s bank details.
Note: Delivery may be delayed as it may take a few days for the amount to be credited to Betachek’s account. The order will be dispatched at the earliest as soon as the receipt of payment has been booked.
In the case of the PayPal and Sofort payment methods, settlement is carried out by a payment service provider. Your payment data will be passed on to the respective payment service provider for payment processing. Betachek reserves the right to change or add payment methods or the payment service provider.
The text of the contract will be saved by Betachek after conclusion of the contract and can be requested by you (Art. 246c para. 2 EGBGB).
3. Prices

The prices to be taken from the online shop at the time of the order shall apply. All prices include the respective statutory value added tax. The respective shipping costs are shown separately.

4. Contact
You can find our contact details here.

Cancellation policy

You have the right to cancel this contract within fourteen days without giving any reason.
The withdrawal period is fourteen days from the day on which you or a third party named by you, who is not the carrier, has or has taken possession of the goods. In the case of a contract for several goods which you have ordered as part of a single order and which are delivered separately, the cancellation period is fourteen days from the day on which you or a third party named by you, who is not the carrier, have taken or has taken possession of the last goods.
To exercise your right of withdrawal, you must inform us of your decision to withdraw from this contract by means of a clear declaration (e.g. a letter or e-mail sent by post).
In order to comply with the withdrawal period, it is sufficient that you send the notification of the exercise of the right of withdrawal before the expiry of the withdrawal period.
Betachek guarantees a full refund of the purchase price for returned items purchased from the Betachek online shop, provided that all items are returned in the condition in which they were received.
This means that the items, including their packaging, must not be used, damaged, soiled or altered in any way.
This is essential in relation to blood testing equipment to prevent cross-contamination and transmission of disease and to ensure that hygiene and sterility are maintained. These products cannot be returned after use. If the sterile packaging of the product is opened, unwrapped or tampered with, the product is considered used and cannot be returned.

Quality agreement – commercial customers

Quality Assurance Agreement for the Distribution of Medical Devices and In Vitro Diagnostics Manufactured by National Diagnostic Products Pty Limited, 7-9 Merriwa Street, Gordon NSW, Australia, (represented by the European Commission Representative, Betachek GmbH, Am Dorbach 12, 52076 Aachen, Germany), hereinafter referred to as the “Manufacturer”.
The purpose of these clauses is to ensure that the Manufacturer complies with the directives and laws relating to the marketing of medical devices and in vitro diagnostics (hereinafter referred to as “Products”). In order to achieve this, all distributors of the Manufacturer (hereinafter referred to as “Distributors”) must cooperate.
Article 1: Legal basis
The following paragraphs cover requirements for distribution, quality assurance, service, market surveillance and reporting in particular, but not exclusively, of the following directives, laws and standards:
  • Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices.
  • Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices
  • Medical Devices Act in the version published on 07.08.2002, last amended by Art. 12 of the Act of 24.07.2010 (BGBl. I, p. 983).
  • Medical Devices Regulations SOR/98-282 published by the Canadian Minister of Justice.
  • Quality System Regulation from the Code of Federal Regulations, Title 21, Part 820 of the US Food and Drug Administration of the United States of America as amended on 01.04.2010.
  • Standard EN ISO 13485:2016 + AC:2016 – Standard ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
Insofar as the Medical Devices Act, the Product Liability Act and the laws, standards and guidelines mentioned in the preamble are referred to in the following provisions, existing medical device laws, guidelines or administrative directives with binding effect with regard to the respective contractual territory, whether present or future, shall always be deemed to have been agreed as supplementary.
Article 2: Traceability of medical devices
The distributor is obliged to keep distribution records and to retain them for at least the intended duration of the Medical Devices Act and the corresponding national and international guidelines, as well as the laws, standards and guidelines mentioned in the preamble, but for at least 10 years. The following regulations on traceability do not apply within Germany: The distribution records must contain detailed information necessary for the traceability of the product. The distribution records must make it possible to carry out corrective and preventive actions as well as recalls. These records are exclusively necessary for the implementation of measures of the Medical Devices Act, the corresponding national and international directives as well as the Product Liability Act, and the laws, standards and directives mentioned in the preamble and may only be used by the manufacturer for these purposes. If the distributor does not comply with these obligations, he is not entitled to place the products on the market or is obliged to indemnify the manufacturer against all claims arising from the placing of the products on the market.
Article 3: Market and Product Monitoring Duty, Instruction Duty, Customer Complaints and Quality Control

The distributor is obliged to observe the market and the products in its contractual territory and to inform the manufacturer promptly in writing of all non-conforming products, lack of safety or effectiveness of the products or of restrictions of the product properties promised in the manufacturer’s product information. The distributor is obliged to install an appropriate quality assurance system to fulfil these obligations resulting from the Medical Devices Act and the respective directives, so that the manufacturer can analyse the causes of non-conforming products on this basis, develop countermeasures and implement them accordingly.
In order to enable the manufacturer to comply with the legal notification deadlines resulting from the laws and directives, the distributor must design a corresponding quality assurance system in such a way that he can notify the manufacturer within three working days of incidents that have affected the safety or effectiveness of the product.

Article 4: National product registrations, regulations and laws
The dealer outside Germany is responsible for compliance with the national directives and laws applicable to the distribution of the products in the respective contractual territories. He shall, if necessary, after consultation, on behalf of and, as far as legally permissible, in the name of the manufacturer, as local authorised representative (agent), carry out the registrations and approvals with the national authorities of his country which are necessary or expedient for the operation of the products. In doing so, the distributor must inform the manufacturer in writing of any obligations resulting from this for the manufacturer, naming the text of the directive or law and specifying where it can be found. The distributor has the obligation to inform the manufacturer about such concluded measures and their scope and period of validity (e.g. of product registrations) as well as to hand over to the manufacturer the corresponding proofs such as e.g. certificates of authorities in copy, if the manufacturer is the owner of the registration in the original. The trader assigns all rights arising from product registrations and product approvals to the manufacturer accepting this, to the extent permitted by law.
Article 5: Data security
The dealer is obliged to keep all data which he receives from manufacturers and customers within the framework of this contract secret and also to secure and store it in accordance with the respective national data protection laws. The data may only be used for the purposes of the contract and must be kept or made available to the manufacturer for as long as the manufacturer’s obligation to safeguard data vis-à-vis the authorities exists and is additionally required by national data protection regulations.