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CPAP Face Mask Set w/Hose, M
EUDAMEDClass IIa (EU MDR)
Ref AM0121Model (M) Non invasive ventilation (NIV) Mask
Identity
- Trade Name
- CPAP Face Mask Set w/Hose, M EUDAMED
- Device Name
- CPAP Mask EUDAMED
- Model / Reference
- (M) Non invasive ventilation (NIV) Mask EUDAMEDAM0121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810117275 EUDAMED
- Basic UDI-DI
- 471081008NNMM9M EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa 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
CPAP Face Mask Set w/Hose, M by GaleMed Corporation — 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 | 471081008NNMM9M | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 73d22d1a-d9fc-494f-9bc8-352473512147 61 fields · synced Jul 19, 2026