Identity
- Trade Name
- IDS-i10 EUDAMEDFDA UDI
- Generic Name
- Multichannel immunoassay analyser IVD FDA UDI
- Device Name
- IDS-i10 EUDAMED
- Model / Reference
- IS-810400 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169693968 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169693968YX EUDAMED
- 510(k) Number
- K091849 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
- GMDN Term
- Multichannel immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
IDS-i10 by Immunodiagnostic Systems Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5060169693968YX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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 df046a84-be42-4e37-b766-6b15fb728f5c 61 fields · synced Jul 11, 2026
- FDA UDI 8a56e9af-dd99-4182-8fb2-bf6f598b3de3 35 fields · synced May 30, 2026