Mouth Tape
by Dongguan Xinhongke Adhesive Products Co., Ltd. EUDAMED
Active
Ref XH501Model XHK601 XHK602 XHK605 XHK608 XHK609 XHK6010 XH501 XH502 XH505 XH507 XH509 XH5010 801 802 8015 8010 8080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698010006MOTLJ | Date19 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Mouth Tape
- Model / Reference
- XHK601 XHK602 XHK605 XHK608 XHK609 XHK6010 XH501 XH502 XH505 XH507 XH509 XH5010 801 802 8015 8010 8080, XH501
- Primary DI / UDI-DI
- 06980100060651
- Basic UDI-DI
- 698010006MOTLJ
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000054518
- Authorised representative
- HyperCert Limited B.V. NL-AR-000047746
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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