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Agnitio BioIC Analyzer
EUDAMEDClass A (EU MDR)
Ref BA-G2000 seriesModel BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 seriesRef BA2400 seriesRef BA-G2012 seriesRef BA1200 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 EUDAMEDBA-G2000 series EUDAMEDBA2400 series EUDAMEDBA-G2012 series EUDAMEDBA1200 series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892999014 EUDAMED04719892999069 EUDAMED04719892999021 EUDAMED04719892999076 EUDAMED
- Basic UDI-DI
- 471989299Analyzer8A EUDAMED
- Direct Marketing DI
- 04719892999014 EUDAMED04719892999069 EUDAMED04719892999021 EUDAMED04719892999076 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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 (4)
- EUDAMED 3d80d194-7fcc-4e5d-b046-0d64b3a54b2c 61 fields · synced Aug 3, 2026
- EUDAMED 51219cf1-9793-41dd-b414-0761cc8f2a6e 61 fields · synced May 17, 2026
- EUDAMED ab86c69f-20c4-4002-bc4e-1afba00d55a4 61 fields · synced May 17, 2026
- EUDAMED f3ac5107-8afb-46ed-82de-71d35262f912 61 fields · synced May 18, 2026