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Airgap High Flow Nasal Cannula XL
EUDAMEDClass IIa (EU MDR)
Ref TKMD2003
by Foxxmed Ltd
Identity
- Trade Name
- Airgap High Flow Nasal Cannula XL EUDAMED
- Device Name
- Airgap High Flow Nasal Cannula XL EUDAMED
- Model / Reference
- TKMD2003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876361370 EUDAMED
- Basic UDI-DI
- B-04719876361370 EUDAMED
- EMDN Code
- R0301020302 HIGH FLOW THERAPY NASAL CANNULAS (HFNC) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Airgap High Flow Nasal Cannula XL by Foxxmed Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719876361370 | Class IIa | 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 a5c56ebb-d80f-4b8d-af7f-fdae37eb867e 61 fields · synced Jun 19, 2026