Identity
- Trade Name
- AST-Reagent Kit EUDAMED
- Device Name
- AST-Reagent Kit EUDAMED
- Model / Reference
- AST-Reagent Kit EUDAMEDE2-323-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251204327028 EUDAMED
- Basic UDI-DI
- 425120430200001020FC EUDAMED
- EMDN Code
- W010403060101 SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL 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
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
AST-Reagent Kit 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 | 425120430200001020FC | Class A | Active |
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Manufacturer
- Manufacturer
- Bruker Daltonics GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000024392
Sources (1)
- EUDAMED b872e0ba-e079-4c6c-85c6-d5829ef10ae5 61 fields · synced Jun 18, 2026