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ST AIA-PACK Thyroglobulin CALIBRATOR SET
EUDAMEDClass IVD General (EU MDR)
Ref 0025327Ref 0025227
Identity
- Device Name
- ST AIA-PACK Thyroglobulin CALIBRATOR SET EUDAMEDST AIA-PACK Thyroglobulin EUDAMED
- Model / Reference
- 0025327 EUDAMED0025227 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560189212848 EUDAMED14560189212821 EUDAMED
- Basic UDI-DI
- B-04560189212848 EUDAMEDB-14560189212821 EUDAMED
- EMDN Code
- W01020408 THYROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
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
ST AIA-PACK Thyroglobulin CALIBRATOR SET by Tosoh Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04560189212848 | Class IVD General | 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 1279d8c9-c3c8-481b-8b25-5764db1b809b 61 fields · synced Jul 28, 2026
- EUDAMED d6c223aa-c48d-44a7-998d-7feac04d08e8 61 fields · synced May 18, 2026