Identity
- Device Name
- NIV face mask EUDAMED
- Model / Reference
- 1703 EUDAMED1702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873291717 EUDAMED04719873291700 EUDAMED
- Basic UDI-DI
- 47198732920VN EUDAMED
- Direct Marketing DI
- 04719873291717 EUDAMED04719873291700 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
NIV face mask by Da Chung Medical Co., Ltd. — Class IIa — 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 | 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 (2)
- EUDAMED 9386bb19-3b0f-4f1b-bb51-4f493830e5b5 61 fields · synced Jul 30, 2026
- EUDAMED efcd6b59-881f-4f34-95a0-9e5ec702aa90 61 fields · synced May 17, 2026