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MBT STAR-Cepha IVD Kit
EUDAMEDClass C (EU MDR)
Ref 1858555Model MBT STAR-Cepha IVD Kit
Identity
- Trade Name
- MBT STAR-Cepha IVD Kit EUDAMED
- Device Name
- MBT STAR-Cepha IVD Kit EUDAMED
- Model / Reference
- MBT STAR-Cepha IVD Kit EUDAMED1858555 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251204326007 EUDAMED
- Basic UDI-DI
- 425120430100001010EJ EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General-microorganism antimicrobial susceptibility culture medium IVD
MBT STAR-Cepha IVD Kit by Bruker Daltonics GmbH & Co. KG — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 425120430100001010EJ | Class C | Active |
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Manufacturer
- Manufacturer
- Bruker Daltonics GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000024392
Sources (1)
- EUDAMED 8850b5f7-ca9a-4c00-bf28-be96f55b943f 61 fields · synced Jul 20, 2026