Identity
- Trade Name
- SepsiTest™-UMD CE IVD EUDAMED
- Device Name
- SepsiTest™-UMD CE IVD EUDAMED
- Model / Reference
- U-010-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-U-010-0483K EUDAMED
- Basic UDI-DI
- B-U-010-0483K EUDAMED
- EMDN Code
- W0105900101,W0105900102 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
SepsiTest™-UMD CE IVD by Molzym GmbH & Co.KG — 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-U-010-0483K | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Molzym GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000037419
Sources (2)
- EUDAMED f532b259-222e-4cc0-b1e0-b7b6c998453b 61 fields · synced Jun 18, 2026
- EUDAMED 2260e416-3c4a-4b9c-8017-04033452a480 61 fields · synced Jun 11, 2026