Identity
- Trade Name
- 15L Cycler Drainage Bag Non-Sterile EUDAMED
- Device Name
- 15L Cycler Drainage Bag Non-Sterile EUDAMED
- Model / Reference
- R5C4145NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332414003654 EUDAMED
- Basic UDI-DI
- 7332414VA0000973Q EUDAMED
- EMDN Code
- F020280 PERITONAEAL DIALYSIS LINES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
15L Cycler Drainage Bag Non-Sterile by Vantive Health GmbH — Class I — 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 | 7332414VA0000973Q | Class I | Active |
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Manufacturer
- Manufacturer
- Vantive Health GmbH
- EUDAMED SRN
- CH-MF-000038981
- Authorised Representative
- Vantive S.r.l. IT-AR-000041309
Sources (1)
- EUDAMED dd8ff527-5c3f-428d-b546-f6e1c4301f7c 61 fields · synced Jul 24, 2026