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Mediflex
EUDAMEDClass IIa (EU MDR)
Ref FBT 12-000Model T-Piece Resuscitator Breathing Circuit
Identity
- Trade Name
- MEDIFLEX EUDAMED
- Device Name
- Ventilator Breathing Circuit EUDAMED
- Model / Reference
- T-Piece Resuscitator Breathing Circuit EUDAMEDFBT 12-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681277829123 EUDAMED
- Basic UDI-DI
- 868127782TD-028EY EUDAMED
- Direct Marketing DI
- 08681277829123 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 — 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-028EY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mediflex Medikal
- EUDAMED SRN
- TR-MF-000036464
Sources (1)
- EUDAMED ff2b383a-1887-4181-9856-2e00489931cc 61 fields · synced Jun 18, 2026