Identity
- Device Name
- Serazym® Verotoxin 1+2 EUDAMED
- Model / Reference
- E-030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099466103031 EUDAMED
- Basic UDI-DI
- B-04099466103031 EUDAMED
- EMDN Code
- W0105011502 E. COLI TOXIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Serazym® Verotoxin 1+2 by Seramun Diagnostica GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04099466103031 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Seramun Diagnostica GmbH
- EUDAMED SRN
- DE-MF-000026029
Sources (1)
- EUDAMED bcd8df07-3306-4453-a3cd-92ad43fe7bc1 61 fields · synced Jul 24, 2026