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Headgear for Nasal Mask
EUDAMEDClass I (EU MDR)
Ref AM0118Model (A) HeadgearRef AM0042
Identity
- Trade Name
- Headgear for Nasal Mask EUDAMEDHeadgear for Nasal Mask, L EUDAMED
- Device Name
- Reusable Headgear EUDAMED
- Model / Reference
- (A) Headgear EUDAMEDAM0118 EUDAMEDAM0042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810101656 EUDAMED04710810084942 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 Nasal Mask 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 (2)
- EUDAMED f2bf9731-dd83-469b-acec-3c2c9ea69540 61 fields · synced Jul 19, 2026
- EUDAMED 86d1e0aa-8642-4c7b-9f97-498f5c6eaee5 61 fields · synced May 19, 2026