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Cl Aia-Pack Sample Diluting Reagent Z
EUDAMEDClass IVD General (EU MDR)
Ref 0029410
Identity
- Trade Name
- CL AIA-PACK SAMPLE DILUTING REAGENT Z EUDAMED
- Device Name
- CL AIA-PACK SAMPLE DILUTING REAGENT Z EUDAMED
- Model / Reference
- 0029410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189216317 EUDAMED
- Basic UDI-DI
- B-14560189216317 EUDAMED45601892100010497N EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Cl Aia-Pack Sample Diluting Reagent Z by Tosoh Corporation — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-14560189216317 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-14560189216317 | Class IVD General | Active |
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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 feec9d1f-746a-46d2-8fc4-6af3f9734a57 61 fields · synced Sep 18, 2026
- EUDAMED cf5c0b39-1ed5-4ff6-89c5-dcf0c0220749 61 fields · synced May 16, 2026
- EUDAMED 7392c236-cda4-4705-974f-b9640cc0cd79 61 fields · synced Sep 18, 2026