Identity
- Trade Name
- MK-ADULT HIGH FLOW-SM EUDAMED
- Device Name
- MK-ADULT HIGH FLOW-SM EUDAMED
- Model / Reference
- MKMD2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876360434 EUDAMED
- Basic UDI-DI
- B-04719876360434 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
Mk-Adult High Flow-Sm 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-04719876360434 | 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 87bbfae9-0f6d-408a-8733-dd434a4a129a 61 fields · synced Jul 13, 2026