Identity
- Trade Name
- ST AIA-PACK HGH FDA UDI
- Generic Name
- Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ST AIA-PACK HGH EUDAMED
- Model / Reference
- 0025266 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14560189210452 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14560189210452 EUDAMED
- FDA Product Code
- CFL FDA UDI
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
- GMDN Term
- Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1370 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
Yes
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 Hgh 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-14560189210452 | 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 3f37bdc5-7826-4a76-8ba6-bcf7fa570537 61 fields · synced Jul 11, 2026
- FDA UDI 4bb38061-6c5c-4705-ae89-77b70a22f212 34 fields · synced May 29, 2026