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Classic 15 Sefam
EUDAMEDClass IIa (EU MDR)
Ref HUE15018GT0030GIModel Classic : tube models consist of different lengths and diameters, different rib Colour, flexibility of cuff and tube
Identity
- Trade Name
- Classic 15 Sefam EUDAMED
- Device Name
- Non-heated respiratory tubes EUDAMED
- Model / Reference
- Classic : tube models consist of different lengths and diameters, different rib Colour, flexibility of cuff and tube EUDAMEDHUE15018GT0030GI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404013000821 EUDAMED
- Basic UDI-DI
- 54040130000000000000067 EUDAMED
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Classic 15 Sefam by Plastiflex Group NV — 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 | 54040130000000000000067 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Plastiflex Group NV
- EUDAMED SRN
- BE-MF-000008049
Sources (1)
- EUDAMED 1ba44cbf-7a8b-45bf-a6f8-ce8169d951fb 61 fields · synced Jul 16, 2026