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SepsiTest™-UMD CE IVD
EUDAMEDClass IVD General (EU MDR)
Ref U-010-024Model U-010-024
Identity
- Trade Name
- SepsiTest™-UMD CE IVD EUDAMED
- Device Name
- SepsiTest™-UMD CE IVD EUDAMED
- Model / Reference
- U-010-024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-U-010-02435 EUDAMED
- Basic UDI-DI
- B-U-010-02435 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-010-02435 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Molzym GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000037419
Sources (2)
- EUDAMED bf02bd73-1eb5-4e55-aabb-3898a9afbfb9 61 fields · synced Jun 19, 2026
- EUDAMED 81008ad1-2e6a-4ea7-b4d4-97a1c189350f 61 fields · synced Jun 19, 2026