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MBT HT Mycobacteria IVD Module
EUDAMEDClass C (EU MDR)
Ref 1877012Model MBT HT Mycobacteria IVD Module
Identity
- Trade Name
- MBT HT Mycobacteria IVD Module EUDAMED
- Device Name
- MBT HT Mycobacteria IVD Module EUDAMED
- Model / Reference
- MBT HT Mycobacteria IVD Module EUDAMED1877012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251204326731 EUDAMED
- Basic UDI-DI
- 425120430100001008EX EUDAMED
- EMDN Code
- W02039092 VARIOUS MICROBIOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
MBT HT Mycobacteria IVD Module by Bruker Daltonics GmbH & Co. KG — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 425120430100001008EX | Class C | Active |
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Manufacturer
- Manufacturer
- Bruker Daltonics GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000024392
Sources (1)
- EUDAMED e54c0b3c-8927-4767-9ee5-a20443e7a5bb 61 fields · synced Jun 18, 2026