Identity
- Device Name
- Mouthpiece EUDAMED
- Model / Reference
- 26607 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897760589 EUDAMED
- Basic UDI-DI
- 471989776266NG EUDAMED
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES EUDAMED
Classification
- Device Class
- Class I 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
Mouthpiece by Winnomed Company 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 | 471989776266NG | Class I | Active |
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Manufacturer
- Manufacturer
- Winnomed Company Ltd.
- EUDAMED SRN
- TW-MF-000037459
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6956be1b-0fa9-4601-b1ff-0c1e832eca02 61 fields · synced Jul 13, 2026