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Headgear for CPAP Mask, White
EUDAMEDClass I (EU MDR)
Ref AM0080Model (A) Headgear
Identity
- Trade Name
- Headgear for CPAP Mask, White EUDAMED
- Device Name
- Disposable Headgear EUDAMED
- Model / Reference
- (A) Headgear EUDAMEDAM0080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810101663 EUDAMED
- Basic UDI-DI
- 471081008NNAM8H EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I 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
Headgear for CPAP Mask, White by GaleMed Corporation — Class I — 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 | 471081008NNAM8H | Class I | 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 ab46fe9b-ade0-4234-955d-54163926d443 61 fields · synced Jun 17, 2026