Identity
- Trade Name
- CL AIA-PACK SAMPLE DILUTING REAGENT I EUDAMED
- Device Name
- CL AIA-PACK SAMPLE DILUTING REAGENT I EUDAMED
- Model / Reference
- 0029409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189216140 EUDAMED
- Basic UDI-DI
- 45601892100010487L EUDAMEDB-14560189216140 EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Cl Aia-Pack Sample Diluting Reagent I by Tosoh Corporation — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 45601892100010487L | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 45601892100010487L | Class A | Active |
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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 2fa528e0-39ef-4954-837d-096ee8e93d3c 61 fields · synced Jul 16, 2026
- EUDAMED 7bd0f18f-6bf1-41fd-90d5-5bf388082cec 61 fields · synced May 19, 2026