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NIV-DL Mask, M
EUDAMEDClass IIa (EU MDR)
Ref AM0069Model (M) Non invasive ventilation (NIV) Mask
Identity
- Trade Name
- NIV-DL Mask, M EUDAMED
- Device Name
- NIV Mask EUDAMED
- Model / Reference
- (M) Non invasive ventilation (NIV) Mask EUDAMEDAM0069 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810101506 EUDAMED
- Basic UDI-DI
- 471081008NNM27Z EUDAMED
- EMDN Code
- R0301010202 NIV 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
Category: Rebreathing oxygen face mask
NIV-DL Mask, M by GaleMed Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 471081008NNM27Z | 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 770fb7c8-5047-4eea-afe0-5b0ce50c6f18 61 fields · synced Jul 9, 2026