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ST AIA-PACK Testosterone CALIBRATOR SET
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0025304
Identity
- Trade Name
- ST AIA-PACK Testosterone CALIBRATOR SET FDA UDI
- Generic Name
- Total testosterone IVD, calibrator FDA UDI
- Device Name
- ST AIA-PACK Testosterone CALIBRATOR SET EUDAMED
- Model / Reference
- 0025304 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211339 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189211339 EUDAMED
- FDA Product Code
- CDZ FDA UDI
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
- GMDN Term
- Total testosterone IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1680 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
Yes
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
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
ST AIA-PACK Testosterone CALIBRATOR SET 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-04560189211339 | 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 d55bcea0-54f5-48f2-9470-e8834c816837 61 fields · synced Jun 18, 2026
- FDA UDI 08d2fe86-a24d-45d4-a42d-d559f579b316 34 fields · synced May 30, 2026