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- Hybernite ROC EU
EUDAMEDClass IIa (EU MDR)
Ref HHE19018WT0ECBCK Model Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff
Identity
- Trade Name
- - Hybernite ROC EU 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 EUDAMEDHHE19018WT0ECBCK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404013004546 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
- Hybernite ROC EU 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 18d82419-90ab-495f-874b-923d531f9782 61 fields · synced Jun 17, 2026