Identity
- Trade Name
- OMNIset® EUDAMED
- Device Name
- OMNIset CRRT (Saxonia) EUDAMED
- Model / Reference
- 7211429 EUDAMED7211425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046955317349 EUDAMED04046955317103 EUDAMED
- Basic UDI-DI
- 40392390000005492N EUDAMED
- EMDN Code
- F0306 CONTINUOUS DIALYSIS KITS EUDAMED
Classification
- Device Class
- Class IIb 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
OMNIset® by B.Braun Avitum AG — Class IIb — 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 | 40392390000005492N | Class IIb | Active |
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Manufacturer
- Manufacturer
- B. Braun Avitum AG
- EUDAMED SRN
- DE-MF-000005127
Sources (2)
- EUDAMED c2fafdde-1d00-4f3b-8fe9-b9175a344ee8 61 fields · synced Jul 9, 2026
- EUDAMED b7dfd398-f727-4d7e-926e-0612044bfa9f 61 fields · synced Jul 8, 2026