Identity
- Trade Name
- AIA-PACK SUBSTRATE SET II EUDAMEDFDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence FDA UDI
- Device Name
- AIA-PACK SUBSTRATE SET II EUDAMED
- Model / Reference
- 0020968 EUDAMEDn/a FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211742 EUDAMEDFDA UDI
- Basic UDI-DI
- 456018921000006277 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aia-Pack Substrate Set Ii by Tosoh Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 456018921000006277 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 86c9e137-c22d-4e7a-86ce-d9d9ea5daaba 61 fields · synced Jul 12, 2026
- FDA UDI 27c3df4b-9298-4db1-a8e8-599a5c20da10 34 fields · synced May 29, 2026