1. Purpose
The purpose of these General Terms and Conditions of Sale (GTC) is to define the terms and conditions applicable to any sale of products or
medical devices made by Tongue Tech Limited (“Tongue Tech”) to its professional customers (“the Customer”). Any order implies the Customer’s unreserved acceptance of these GTC, which prevail over any other document.

2. Prices
The sales prices are listed on the previous page or in the quote provided. They are expressed in euros excluding VAT. The applicable VAT (20%) is applied to the total amount of the order excluding VAT. Tongue Tech reserves the right to modify its prices at any time, but products will be invoiced at the prices in force at the time of the order.

3. Delivery
Delivery costs are not included in the prices indicated. They will be added to the final invoice. The estimated delivery time is approximately three working days in mainland France. Tongue Tech cannot be held responsible for any delay caused by force majeure, a carrier, or any event beyond its control. Any urgent delivery must be expressly mentioned in the order form or comments. Signing the delivery note constitutes an acknowledgement of the goods’ conformity.

4. Terms of payment
Prepayment: 50% of the total amount, including VAT, at the time of order. Remaining balance, including shipping costs, is payable within 8 days of receipt of the final invoice. Payments by bank transfer to Tongue Tech Ltd. IBAN: IE41 REVO 9903 6043 4452 31- BIC: REVOIE23
Reference to be indicated: Tongue Tech order or invoice number. In the event of late payment, late payment penalties may be applied in
accordance with Article L441-10 of the French Commercial Code, as well as a fixed collection fee of €40.

5. Order cancellation
Any order may be cancelled no later than 8 days before the scheduled delivery date. For orders that have already been delivered, cancellations will only be accepted for products with intact, unopened packaging. In this case, a penalty of 30% of the total amount, including VAT, will be applied and retained by Tongue Tech. No returns will be accepted without prior written agreement.

6. Retention of title clause
The products sold remain the exclusive property of Tongue Tech until full payment of the price (principal and accessories). The transfer of risk occurs upon delivery to the Customer.

7. Regulatory compliance and CE marking
The TPMD is a Class Im medical device, compliant with European regulations (EU Regulation 2017/745). It bears the CE marking under this regulation. Manufacturer: JMS Co. Ltd (Japan) European importer: Bionic GmbH (Germany), a subsidiary of JMS Distributor in Europe: Tongue Tech Limited.

8. Usage and safety information
The TPMD device and its consumables are intended for measuring tongue strength and endurance as part of screening, diagnosis, or functional rehabilitation monitoring. The intraoral probes are for single, individual use. Once unsealed, they cannot be cleaned, sterilised, or reused. The connection tubes can be reused for several patients after appropriate cleaning. It is mandatory to carefully read the user manual provided with the first order before use.

9. Traceability and warranty
Tongue Tech ensures the regulatory traceability of the TPMD and related consumables. The customer, as purchaser and owner, undertakes to keep the device identification data and to report any anomalies to Tongue Tech. A17-month warranty from the date of receipt covers TPMD devices. In the event of a defect, the product must be returned to Tongue Tech, accompanied by a copy of the invoice. Consumables (probes, tubes) are excluded from the warranty.

10. Applicable law and jurisdiction
These GTC are subject to French law. Any dispute relating to their interpretation or execution shall be submitted to the Paris Commercial Court, unless otherwise required by law.

11. Intended Use and Professional Scope of the Purchaser
By placing an order, the purchaser expressly acknowledges that: 1/ The use of the TPMD is the purchaser’s sole responsibility and must fall strictly within the scope of practice permitted by the regulations applicable to their profession in their country of exercise. 2/ The purchaser holds the professional qualifications or training required for the appropriate use of the device or undertakes to complete the user training made available by Tongue Tech Limited at the time of purchase. 3/ Tongue Tech Limited shall not be liable for any use of the TPMD outside the purchaser’s legal scope of practice, nor for any use that does not comply with the instructions for use supplied with the device. Tongue Tech Limited reserves the right to refuse any order where the intended use appears manifestly inconsistent with applicable regulations.

12. Liability and proper use
Tongue Tech cannot be held liable for improper use, unauthorised modification or repair, or use outside the scope of the indications. The Customer undertakes to comply with hygiene requirements, to inform
patients, and to use the device exclusively in a professional setting.

13. Regulatory obligations and vigilance
The Customer undertakes to keep information regarding the serial number, batch, and date of purchase, to notify Tongue Tech immediately of any incident or adverse effect, and to cooperate in the event of a recall or a medical device vigilance investigation.

14. Personal data and traceability (GDPR/MDR)
Specific professional data may be collected for traceability purposes. This data is strictly limited to this regulatory use and is never transmitted to unauthorised third parties. Tongue Tech collects no patient data. The Customer has the right to access, rectify, and object to this data.

15. Maintenance, technical support, and updates
Tongue Tech provides technical support upon request. All maintenance must be carried out by Tongue Tech, the importer or its authorised partners.

16. Product recall or security update
In the event of a recall or security patch, Tongue Tech will notify the Customer electronically. The Customer agrees to cooperate actively in
removing or replacing the affected products.

17. Intellectual property
The trademarks, logos, manuals, and technical documents associated with the TPMD are the exclusive property of JMS or Tongue Tech, as the case may be. Any unauthorised reproduction or distribution is prohibited.

18. Force majeure
In the event of force majeure (strike, pandemic, supply disruption, administrative ban, etc.), the obligations of the parties shall be suspended for the duration of the event.

19. Tolerance and partial invalidity
The fact that Tongue Tech does not invoke a clause at a given time does not constitute a waiver of its right to invoke it at a later date. If a clause is deemed invalid, the other provisions shall remain applicable.

20. Contact
Tongue Tech Limited French Branch Office address: 240, rue Saint Jacques – 75005 Paris – France

Email: contact@tongue-tech.com

Telephone: +33 146 338 667

Website: www.tongue-tech.com