← Back to catalogue
IDS-iSYS Total Testosterone
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref IS-5000
Identity
- Trade Name
- IDS-iSYS Total Testosterone EUDAMED
- Device Name
- IDS-iSYS Total Testosterone EUDAMED
- Model / Reference
- IS-5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169690721 EUDAMED
- Basic UDI-DI
- B-05060169690721 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) 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
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
IDS-iSYS Total 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 | K252728 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-05060169690721 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED c3c96358-d95f-4799-8638-24eb07cfb51c 61 fields · synced Jul 12, 2026
- FDA 510(k) K252728 1 fields · synced May 18, 2026