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ST AIA-PACK cTnI 3rd-Gen CALIBRATOR SET
EUDAMEDClass IVD General (EU MDR)
Ref 0025315Ref 0025215
Identity
- Device Name
- ST AIA-PACK cTnI 3rd-Gen CALIBRATOR SET EUDAMEDST AIA-PACK cTnI 3rd-Gen EUDAMED
- Model / Reference
- 0025315 EUDAMED0025215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560189211056 EUDAMED14560189210148 EUDAMED
- Basic UDI-DI
- B-04560189211056 EUDAMEDB-14560189210148 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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 cTnI 3rd-Gen 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-04560189211056 | 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 1aa1e664-e89d-4847-9d90-3408aec33606 61 fields · synced Jul 21, 2026
- EUDAMED a2e738c7-acda-419c-8da4-ea7f703a8b73 61 fields · synced May 17, 2026