Identity
- Trade Name
- CL AIA-PACK DETECTOR STANDARDIZATION CUP EUDAMED
- Device Name
- CL AIA-PACK DETECTOR STANDARDIZATION CUP EUDAMED
- Model / Reference
- 0029705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14562185395614 EUDAMED
- Basic UDI-DI
- 456018921000100674 EUDAMED
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
New Device
No
EUDAMED
Cl Aia-Pack Detector Standardization Cup by Tosoh Corporation — Class A — 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 | 456018921000100674 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (1)
- EUDAMED e9799393-360e-4952-b5c3-396f51ee2efc 61 fields · synced Jun 19, 2026