Identity
- Trade Name
- CL AIA-PACK CMV IgM ADJUSTER SET EUDAMED
- Device Name
- CL AIA-PACK CMV IgM EUDAMED
- Model / Reference
- 0029261 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189216089 EUDAMED
- Basic UDI-DI
- 45601892100010717F EUDAMED
- EMDN Code
- W0105040204 CMV IGM EUDAMED
Classification
- Device Class
- Class C 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 CMV IgM ADJUSTER SET by Tosoh Corporation — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 45601892100010717F | Class C | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (1)
- EUDAMED 3c37ce96-b5bd-40b8-9273-936487aa0f75 61 fields · synced Jul 9, 2026