Identity
- Trade Name
- Airgap Headgear XS EUDAMED
- Device Name
- Headgear EUDAMED
- Model / Reference
- FMMD2068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876362353 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 XS 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 784c51de-127e-49be-a353-21e40af07a8c 61 fields · synced Aug 4, 2026