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CPAP face mask
EUDAMEDClass IIa (EU MDR)
Ref 1603Ref 1601Ref 1633Ref 1611Ref 1612
Identity
- Device Name
- CPAP face mask EUDAMED
- Model / Reference
- 1603 EUDAMED1601 EUDAMED1633 EUDAMED1611 EUDAMED1612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873291687 EUDAMED04719873291663 EUDAMED04719873292554 EUDAMED04719873291724 EUDAMED04719873291731 EUDAMED
- Basic UDI-DI
- 47198732910VK EUDAMED
- Direct Marketing DI
- 04719873291687 EUDAMED04719873291663 EUDAMED04719873292554 EUDAMED04719873291724 EUDAMED04719873291731 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 |
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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 (5)
- EUDAMED c395f2ce-438d-4641-a60e-9dfd92ceee07 61 fields · synced Aug 3, 2026
- EUDAMED f21df004-c48a-4cef-b3ad-5eb71fef44e0 61 fields · synced May 17, 2026
- EUDAMED ef500647-2c29-4d23-9fc2-b146f1da74ff 61 fields · synced May 17, 2026
- EUDAMED da1f1664-9810-4223-a58e-8bfccdde31df 61 fields · synced May 17, 2026
- EUDAMED 6d3882c9-54dd-4fcc-99ad-86a2dd491df3 61 fields · synced May 19, 2026