Identity
- Device Name
- SM Antibody Detection Kit EUDAMED
- Model / Reference
- 012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976043630129 EUDAMED
- Basic UDI-DI
- B-06976043630129 EUDAMED
- EMDN Code
- W0102100111 SM EUDAMED
Classification
- Device Class
- Class IVD General 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
SM Antibody Detection Kit by iCarbonX IntelliCore (Guangdong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06976043630129 | Class IVD General | 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 fc4c326d-50aa-4d25-90c7-d17bdf9b3c17 61 fields · synced Oct 6, 2026