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IDS-iSYS human Growth Hormone (hGH)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref IS-3700
Identity
- Trade Name
- IDS-iSYS human Growth Hormone (hGH) EUDAMEDFDA UDI
- Generic Name
- Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IDS-iSYS human Growth Hormone (hGH) EUDAMED
- Model / Reference
- IS-3700 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690332 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690332 EUDAMED
- FDA Product Code
- CFL FDA UDI
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
- GMDN Term
- Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay 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
Yes
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
Yes
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
IDS-iSYS human Growth Hormone (hGH) by Immunodiagnostic Systems Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-05060169690332 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED 65a4c416-8acc-4325-8cc4-69cc07d7e94d 61 fields · synced Jul 10, 2026
- FDA UDI d780046d-879a-4820-88f6-093b5d690d28 34 fields · synced May 29, 2026