Identity
- Trade Name
- OMNIbag® EUDAMED
- Device Name
- OMNIbag EUDAMED
- Model / Reference
- 7211431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046955317363 EUDAMED
- Basic UDI-DI
- 40392390000023362H EUDAMED
- EMDN Code
- F90040101 HAEMODIALYSATE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
OMNIbag® by B.Braun Avitum AG — 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 | 40392390000023362H | Class I | Active |
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Manufacturer
- Manufacturer
- B. Braun Avitum AG
- EUDAMED SRN
- DE-MF-000005127
Sources (1)
- EUDAMED de6fed49-9d73-4c20-9aef-657b1011721e 61 fields · synced Jun 20, 2026