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Mediflex
EUDAMEDClass IIa (EU MDR)
Ref MFAE 6618Model Single-Limb Transport Ventilator Breathing Circuit
Identity
- Trade Name
- MEDIFLEX EUDAMED
- Device Name
- Ventilator Breathing Circuit EUDAMED
- Model / Reference
- Single-Limb Transport Ventilator Breathing Circuit EUDAMEDMFAE 6618 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681277825125 EUDAMED08681277825118 EUDAMED
- Basic UDI-DI
- 868127782TD-02FFS EUDAMED
- Direct Marketing DI
- 08681277825125 EUDAMED08681277825118 EUDAMED
- EMDN Code
- R020106 IPPB 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
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-02FFS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mediflex Medikal
- EUDAMED SRN
- TR-MF-000036464
Sources (2)
- EUDAMED 535c19f3-eeb7-4d9f-944f-bbb4350767f3 61 fields · synced Oct 6, 2026
- EUDAMED fbbefafd-e974-429c-a518-3fd05b6ef460 61 fields · synced May 17, 2026