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Portable Automatic Multi-function Analyzer
EUDAMEDClass A (EU MDR)
Ref 3V001Model iCARE-2100
Identity
- Device Name
- Portable Automatic Multi-function Analyzer EUDAMED
- Model / Reference
- iCARE-2100 EUDAMED3V001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175010288 EUDAMED
- Basic UDI-DI
- 6934175002A0001NE EUDAMED
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Portable Automatic Multi-function Analyzer by Changsha Sinocare Inc. — 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 | 6934175002A0001NE | Class A | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2e1f0ba6-5fbe-4fa6-b0cf-4e73f25bf756 61 fields · synced Jul 31, 2026