Identity
- Device Name
- Microarray Scanner EUDAMED
- Model / Reference
- ICX Imager 500 EUDAMED003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976043630037 EUDAMED
- Basic UDI-DI
- 697604363ICXD003Q8 EUDAMED
- Direct Marketing DI
- 06976043630037 EUDAMED
- EMDN Code
- W02050201 MICRO-ARRAY ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
New Device
No
EUDAMED
Microarray Scanner by iCarbonX IntelliCore (Guangdong) Co., Ltd. — 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 | 697604363ICXD003Q8 | Class A | Active |
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Manufacturer
- Manufacturer
- iCarbonX IntelliCore (Guangdong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000045482
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED b5ddc304-c7e3-4be6-825d-b00a8cb4c027 61 fields · synced Oct 6, 2026