Identity
- Device Name
- Oralmedic EUDAMED
- Model / Reference
- 105-0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00362942000020 EUDAMED
- Basic UDI-DI
- 03629421050003FX EUDAMED
- EMDN Code
- Q019007 BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Oralmedic by Epien Medical, Inc. — 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 | 03629421050003FX | Class I | Active |
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Manufacturer
- Manufacturer
- EPIEN Medical, Inc
- EUDAMED SRN
- US-MF-000008278
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED 8a1cde4b-70c0-426f-99d4-911707aa5d8e 61 fields · synced Jul 17, 2026