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Automated Enzyme Immunoassay Analyzer Aia-2000 St
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0022100
Identity
- Trade Name
- AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST EUDAMEDFDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Device Name
- AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 EUDAMED
- Model / Reference
- 0022100 EUDAMEDAIA-2000 ST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189284616 EUDAMEDFDA UDI
- Basic UDI-DI
- 45601892100040017F EUDAMED
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
- GMDN Term
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Automated Enzyme Immunoassay Analyzer Aia-2000 St by Tosoh Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 45601892100040017F | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED d26d4f36-c7cc-4ac6-9156-a22968995c20 61 fields · synced Jul 17, 2026
- FDA UDI 0c7dc128-7d19-4bd9-b927-dd1463d4bd10 34 fields · synced May 30, 2026