Identity
- Trade Name
- IDS-iSYS Direct Renin EUDAMED
- Device Name
- IDS-iSYS Direct Renin EUDAMED
- Model / Reference
- IS-3400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169690387 EUDAMED
- Basic UDI-DI
- B-05060169690387 EUDAMED
- EMDN Code
- W0102060206 RENINE DIRECT 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 Direct Renin by Immunodiagnostic Systems Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060169690387 | 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 (1)
- EUDAMED ef1a283a-c83e-409e-bedb-6e438c7cad26 61 fields · synced May 23, 2026