Identity
- Trade Name
- CL AIA-PACK SUBSTRATE SET EUDAMED
- Device Name
- CL AIA-PACK SUBSTRATE SET EUDAMED
- Model / Reference
- 0029709 EUDAMED0029702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560189216150 EUDAMED04562185395587 EUDAMED
- Basic UDI-DI
- 45601892100010036W EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER 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
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 Substrate Set 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 | 45601892100010036W | 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 15564105-5841-41fb-b3d5-1285af5278c4 61 fields · synced Aug 3, 2026
- EUDAMED 38c44672-24bb-4311-a310-6435168219ba 61 fields · synced May 18, 2026