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Mediflex
EUDAMEDClass IIa (EU MDR)
Ref FAH 614-105/800Model Corrugated Heated Breathing Circuit With Water Trap and Accessories
Identity
- Trade Name
- MEDIFLEX EUDAMED
- Device Name
- Ventilator Breathing Circuit EUDAMED
- Model / Reference
- Corrugated Heated Breathing Circuit With Water Trap and Accessories EUDAMEDFAH 614-105/800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681277824166 EUDAMED
- Basic UDI-DI
- 868127782TD-C21HC EUDAMED
- Direct Marketing DI
- 08681277824166 EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS 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
Category: Ventilator breathing circuit, single-use
Mediflex by Mediflex Medikal — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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-C21HC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mediflex Medikal
- EUDAMED SRN
- TR-MF-000036464
Sources (1)
- EUDAMED b2683065-ea4c-4fa5-b8d7-20119d0f0ea7 61 fields · synced Jun 17, 2026