Identity
- Trade Name
- Airgap Headgear M EUDAMED
- Device Name
- Headgear EUDAMED
- Model / Reference
- FMMD2070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876362377 EUDAMED
- Basic UDI-DI
- 471987636FMDHFNCACCGW EUDAMED
- EMDN Code
- R03010280 OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Airgap Headgear M by Foxxmed Ltd — 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 | 471987636FMDHFNCACCGW | Class I | Active |
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Manufacturer
- Manufacturer
- Foxxmed Ltd
- EUDAMED SRN
- TW-MF-000022145
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED fc177b3b-94cf-4319-ac66-1d6797851b6c 61 fields · synced Jul 30, 2026