Identity
- Trade Name
- i-Track10-C EUDAMED
- Device Name
- IDS-i10 EUDAMED
- Model / Reference
- IS-810400 EUDAMEDTD 810400-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169696587 EUDAMED
- Basic UDI-DI
- 5060169693968YX 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
- Belgium 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
i-Track10-C 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 | 5060169693968YX | Class A | 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 87700512-318b-47a4-a4ff-ecc14b49cf62 61 fields · synced Jun 19, 2026