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Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0024450
Identity
- Trade Name
- Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 EUDAMEDFDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400 EUDAMED
- Model / Reference
- 0024450 EUDAMEDAIA-CL300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04562185404814 EUDAMEDFDA UDI
- Basic UDI-DI
- 45601892100040047M EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 by Tosoh Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 45601892100040047M | 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 6fbc69c7-52d5-47f1-8cea-b154d39824f8 61 fields · synced Jun 17, 2026
- FDA UDI e354f563-4089-4ae2-afb4-c4d4735d4e27 34 fields · synced May 30, 2026