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Cl Aia-Pack Sample Diluting Reagent A
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0029401
Identity
- Trade Name
- CL AIA-PACK SAMPLE DILUTING REAGENT A EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- CL AIA-PACK SAMPLE DILUTING REAGENT A EUDAMED
- Model / Reference
- 0029401 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14562185395393 EUDAMEDFDA UDI
- Basic UDI-DI
- 45601892100010026U EUDAMEDB-14562185395393 EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cl Aia-Pack Sample Diluting Reagent A by Tosoh Corporation — Class A — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 45601892100010026U | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 45601892100010026U | 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 (3)
- EUDAMED c7a9a8fa-4ecc-4ee3-afa5-1f4ba7f30c7a 61 fields · synced Jul 11, 2026
- EUDAMED 80cbd414-c901-4b93-b20b-89699837fc8e 61 fields · synced May 19, 2026
- FDA UDI ca064403-5456-4d0e-aa62-f9d00d20d3f2 34 fields · synced May 30, 2026