Identity
- Trade Name
- i-Tracker10 EUDAMED
- Device Name
- IDS-i10T EUDAMED
- Model / Reference
- IS-810410 EUDAMEDTD 810400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169696594 EUDAMED
- Basic UDI-DI
- 5060169699625Z8 EUDAMED
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
i-Tracker10 by Immunodiagnostic Systems Limited — 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 | 5060169699625Z8 | Class A | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (1)
- EUDAMED b3f91893-58bc-492b-9e03-bb87c6ed3c0b 61 fields · synced Jun 18, 2026