Identity
- Device Name
- NIV face mask EUDAMED
- Model / Reference
- 1701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873291694 EUDAMED
- Basic UDI-DI
- 47198732920VN EUDAMED
- Direct Marketing DI
- 04719873291694 EUDAMED
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
Category: Rebreathing oxygen face mask
NIV face mask by Da Chung Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 47198732920VN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Da Chung Medical Co., Ltd.
- EUDAMED SRN
- TW-MF-000037960
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a9d90d76-5e39-4f81-b8c0-0ac35e5f67bc 61 fields · synced Jun 18, 2026