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Automated Enzyme Immunoassay System Aia-360
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0019945
Identity
- Trade Name
- AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 EUDAMEDFDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Device Name
- AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 EUDAMED
- Model / Reference
- 0019945 EUDAMEDAIA-360 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189282896 EUDAMEDFDA UDI
- Basic UDI-DI
- 45601892100040017F EUDAMED
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 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 System Aia-360 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 5d1aec3a-0bc9-4ed4-a706-bbedbe4a2707 61 fields · synced Jul 9, 2026
- FDA UDI a9eeae2d-b5e0-40d1-b59e-0f63824de4c2 34 fields · synced May 30, 2026