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Agnitio BioIC Analyzer
EUDAMEDClass A (EU MDR)
Ref BA400 seriesModel BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series
Identity
- Trade Name
- Agnitio BioIC Analyzer EUDAMED
- Device Name
- Agnitio BioIC Analyzer EUDAMED
- Model / Reference
- BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series EUDAMEDBA400 series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892999052 EUDAMED
- Basic UDI-DI
- 471989299Analyzer8A EUDAMED
- Direct Marketing DI
- 04719892999052 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A 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
Agnitio BioIC Analyzer by Agnitio Science &technology, Inc. — 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 | 471989299Analyzer8A | Class A | Active |
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Manufacturer
- Manufacturer
- Agnitio Science &technology, Inc.
- EUDAMED SRN
- TW-MF-000040942
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4714881a-4178-4791-bcda-8adf88458868 61 fields · synced Jun 19, 2026