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IDS-iSYS Multi-Discipline Automated System
EUDAMEDClass A (EU MDR)
Ref IS-310400
Identity
- Trade Name
- IDS-iSYS Multi-Discipline Automated System EUDAMED
- Device Name
- IDS-iSYS Multi-Discipline Automated System EUDAMED
- Model / Reference
- IS-310400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760173851003 EUDAMED
- Basic UDI-DI
- 3760173851003YL EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
IDS-iSYS Multi-Discipline Automated System by Immunodiagnostic Systems France — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3760173851003YL | Class A | Active |
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Manufacturer
- Manufacturer
- ImmunoDiagnostic Systems France
- EUDAMED SRN
- FR-MF-000023843
Sources (1)
- EUDAMED d9553d6e-60dd-43fb-a022-f55b9c7b0279 61 fields · synced Jun 19, 2026