Identity
- Device Name
- CPAP face mask EUDAMED
- Model / Reference
- 1602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873291670 EUDAMED
- Basic UDI-DI
- 47198732910VK EUDAMED
- Direct Marketing DI
- 04719873291670 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
CPAP 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 | 47198732910VK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Da Chung Medical Co., Ltd.
- EUDAMED SRN
- TW-MF-000037960
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 6b106d74-a155-46d7-bd9b-0172b2a9cf40 61 fields · synced Jun 20, 2026