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Mouth Tape
EUDAMEDClass I (EU MDR)
Ref SM10246Model SM7638 SM7638K SM8040 SM7638F SM10246Ref SM7638
Identity
- Trade Name
- Mouth Tape EUDAMED
- Device Name
- Mouth Tape EUDAMED
- Model / Reference
- SM7638 SM7638K SM8040 SM7638F SM10246 EUDAMEDSM10246 EUDAMEDSM7638 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979919800213 EUDAMED06979919800176 EUDAMED
- Basic UDI-DI
- 697991980MOT4K EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mouth Tape by Dongguan Samvo Biotechnology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697991980MOT4K | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Samvo Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000052566
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (2)
- EUDAMED 1936f4fb-1ba4-45c5-8bea-8fc9a0c3fb4d 61 fields · synced Oct 6, 2026
- EUDAMED 3ae1b391-12a4-4b30-9b28-1c8a2b3282fc 61 fields · synced May 17, 2026