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Bi-level CPAP-DL face Mask w/port, M
EUDAMEDClass IIa (EU MDR)
Ref AM0047Model (M) Non invasive ventilation (NIV) Mask
Identity
- Trade Name
- Bi-level CPAP-DL face Mask w/port, M EUDAMED
- Device Name
- CPAP Mask EUDAMED
- Model / Reference
- (M) Non invasive ventilation (NIV) Mask EUDAMEDAM0047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810102305 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
Bi-level CPAP-DL face Mask w/port, 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 b5d1013c-ae07-49e4-9f10-1ac960ae9cd6 61 fields · synced Jul 14, 2026