Mouth Tape
by Dongguan Xinhongke Adhesive Products Co., Ltd. China EUDAMED
Ref 8015Model XHK601 XHK602 XHK605 XHK608 XHK609 XHK6010 XH501 XH502 XH505 XH507 XH509 XH5010 801 802 8015 8010 8080
EMDN Q03010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698010006MOTLJ | Date19 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Mouth Tape
- Model / Reference
- XHK601 XHK602 XHK605 XHK608 XHK609 XHK6010 XH501 XH502 XH505 XH507 XH509 XH5010 801 802 8015 8010 8080, 8015
- Primary DI / UDI-DI
- 06980100060736
- 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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See all devices from Dongguan Xinhongke Adhesive Products Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED cfac6859-7190-4cf9-8633-5f2b3c440cce