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ePAP face Mask, S
EUDAMEDClass IIa (EU MDR)
Ref AM0061Model (M) Non invasive ventilation (NIV) Mask
Identity
- Trade Name
- ePAP face Mask, S EUDAMED
- Device Name
- CPAP Mask EUDAMED
- Model / Reference
- (M) Non invasive ventilation (NIV) Mask EUDAMEDAM0061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810101896 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
ePAP face Mask, S 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 3b312787-86ee-4fb7-842c-4b72294789bf 61 fields · synced Jul 11, 2026