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MALDI Biotyper sirius one IVD System
EUDAMEDClass A (EU MDR)
Ref 1890212Model MALDI Biotyper sirius one IVD System
Identity
- Trade Name
- MALDI Biotyper sirius one IVD System EUDAMED
- Device Name
- MALDI Biotyper sirius one IVD System EUDAMED
- Model / Reference
- MALDI Biotyper sirius one IVD System EUDAMED1890212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251204326335 EUDAMED
- Basic UDI-DI
- 425120430100001002EK EUDAMED
- EMDN Code
- W020303 MASS - SPECTROMETRY SYSTEM EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
New Device
No
EUDAMED
MALDI Biotyper sirius one IVD System by Bruker Daltonics GmbH & Co. KG — Class A — 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 | 425120430100001002EK | Class A | Active |
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Manufacturer
- Manufacturer
- Bruker Daltonics GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000024392
Sources (1)
- EUDAMED 62ebbbb0-66e2-43c3-a28a-b0268f621f90 61 fields · synced Jun 18, 2026