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Classic FL 15 HUM
EUDAMEDClass IIa (EU MDR)
Ref HWE15018GT0051GIModel Classic : tube models consist of different lengths and diameters, different rib Colour, flexibility of cuff and tube
Identity
- Trade Name
- Classic FL 15 HUM 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 EUDAMEDHWE15018GT0051GI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404013004669 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
Category: Gas-sampling/monitoring respiratory tubing, single-use
Classic FL 15 HUM by Plastiflex Group NV — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gas-sampling/monitoring respiratory tubing, single-use.
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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 | 54040130000000000000067 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Plastiflex Group NV
- EUDAMED SRN
- BE-MF-000008049
Sources (1)
- EUDAMED 9d926fec-ca5f-4397-bfac-79e47d7b56e0 61 fields · synced Jun 14, 2026