Identity
- Trade Name
- Setback valve EUDAMED
- Device Name
- Urology EUDAMED
- Model / Reference
- 2847001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250273755602 EUDAMED
- Basic UDI-DI
- 42502737NUR70112a000000B6 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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: General-purpose suction system, pneumatic
Setback valve by Fresenius Kabi AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 42502737NUR70112a000000B6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fresenius Kabi AG
- EUDAMED SRN
- DE-MF-000009273
Sources (1)
- EUDAMED a295da5d-1c46-450d-a140-98c3f3158cd2 61 fields · synced Jul 15, 2026