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PEP Aircushion Mask, L
EUDAMEDClass IIa (EU MDR)
Ref AM0036Model (M) Non invasive ventilation (NIV) Mask
Identity
- Trade Name
- PEP Aircushion Mask, L EUDAMED
- Device Name
- CPAP Mask EUDAMED
- Model / Reference
- (M) Non invasive ventilation (NIV) Mask EUDAMEDAM0036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810083174 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
PEP Aircushion Mask, L 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 001e3013-c18c-44d8-b03f-d4e4ba10a706 61 fields · synced Jun 20, 2026