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WM 29067 prismaHYBERNITE
EUDAMEDClass IIa (EU MDR)
Ref HPE19018WT0019GIModel Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff
Identity
- Trade Name
- WM 29067 prismaHYBERNITE EUDAMED
- Device Name
- Active non implantable respiratory devices. EUDAMED
- Model / Reference
- Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff EUDAMEDHPE19018WT0019GI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404013003563 EUDAMED
- Basic UDI-DI
- 54040130000000000000169 EUDAMED
- EMDN Code
- R02010401 CPAP CIRCUITS 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
WM 29067 prismaHYBERNITE 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 | 54040130000000000000169 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Plastiflex Group NV
- EUDAMED SRN
- BE-MF-000008049
Sources (1)
- EUDAMED 5680adb6-0b94-444a-a1d7-32bc96e541a0 61 fields · synced Jun 19, 2026