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IDS-iSYS Free Testosterone
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref IS-5300Ref IS-5330
Identity
- Trade Name
- IDS-iSYS Free Testosterone EUDAMEDIDS-iSYS Free Testosterone Control Set EUDAMED
- Device Name
- IDS-iSYS Free Testosterone EUDAMEDIDS-iSYS Free Testosterone Control Set EUDAMED
- Model / Reference
- IS-5300 EUDAMEDIS-5330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169691230 EUDAMED05060169691247 EUDAMED
- Basic UDI-DI
- B-05060169691230 EUDAMEDB-05060169691247 EUDAMED
- EMDN Code
- W0102050299 PREGNANCY TESTING HORMONES - OTHER EUDAMEDW0102152008 CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
IDS-iSYS Free Testosterone by Immunodiagnostic Systems Limited — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240865 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-05060169691230 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (3)
- EUDAMED d37e2cf0-7d90-4d09-a524-57e89a02917d 61 fields · synced Jul 9, 2026
- EUDAMED 9ec341f8-b1ae-417c-a7cf-2aad00155971 61 fields · synced May 18, 2026
- FDA 510(k) K240865 1 fields · synced May 18, 2026