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ST AIA-PACK 25-OH Vitamin D
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0025234
Identity
- Trade Name
- ST AIA-PACK 25-OH Vitamin D FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ST AIA-PACK 25-OH Vitamin D EUDAMED
- Model / Reference
- 0025234 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14560189213125 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14560189213125 EUDAMED
- FDA Product Code
- MRG FDA UDI
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1825 FDA UDI
- 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
ST AIA-PACK 25-OH Vitamin D by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-14560189213125 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 0e0dae2e-78d5-4b59-9f84-8c130f5a77bd 61 fields · synced Jun 18, 2026
- FDA UDI 7edcf1d6-e926-4345-988c-baae5807383e 34 fields · synced May 29, 2026