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Mediflex
EUDAMEDClass IIa (EU MDR)
Ref FAE 16-000 DX Model Corrugated Special Breathing Circuit
Identity
- Trade Name
- MEDIFLEX EUDAMED
- Device Name
- Ventilator Breathing Circuit EUDAMED
- Model / Reference
- Corrugated Special Breathing Circuit EUDAMEDFAE 16-000 DX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681277829154 EUDAMED
- Basic UDI-DI
- 868127782TD-C29HU EUDAMED
- Direct Marketing DI
- 08681277829154 EUDAMED
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Mediflex by Mediflex Medikal — Class IIa — CE/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 | 868127782TD-C29HU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mediflex Medikal
- EUDAMED SRN
- TR-MF-000036464
Sources (1)
- EUDAMED ca5ed29d-e951-4ca8-a646-ec4e8f817c9f 61 fields · synced Oct 6, 2026