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Headgear for CPAP Mask, S, Silicone
EUDAMEDClass I (EU MDR)
Ref AM0015Model (A) Headgear
Identity
- Trade Name
- Headgear for CPAP Mask, S, Silicone EUDAMED
- Device Name
- Reusable Headgear EUDAMED
- Model / Reference
- (A) Headgear EUDAMEDAM0015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810081439 EUDAMED
- Basic UDI-DI
- 471081008RNAM9D 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, S, Silicone 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 | 471081008RNAM9D | 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 54bacbf5-92a8-44cd-b9cf-814de9ee450c 61 fields · synced Jun 19, 2026