Anti Snore Mouthpiece
by Dongguan Yiyao Science & Technology Development Co., Ltd EUDAMED510(k)
Active
Ref TD-01Model TD-01，TD-02，TD-03
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) 510(k) | NumberK250028 | Date3 Oct 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number697512297ASMSG | Date30 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Device Name
- Anti Snore Mouthpiece
- Model / Reference
- TD-01，TD-02，TD-03, TD-01
- Primary DI / UDI-DI
- 06975122970101
- Basic UDI-DI
- 697512297ASMSG
- EMDN Code
- Q030199 Nasopharyngeal devices - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000043820
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dongguan Yiyao Science & Technology Development Co., Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No