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Portable Automatic Multi-Function Analyzer (iCARE-1300)
EUDAMEDClass A (EU MDR)
Ref 10500075Model iCARE-1300
Identity
- Trade Name
- Portable Automatic Multi-Function Analyzer (iCARE-1300) EUDAMED
- Device Name
- Portable Automatic Multi-Function Analyzer EUDAMED
- Model / Reference
- iCARE-1300 EUDAMED10500075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934175049797 EUDAMED
- Basic UDI-DI
- 6934175002A0002NG EUDAMED
- Direct Marketing DI
- 16934175049797 EUDAMED
- EMDN Code
- W02010399,W0202010101 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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 (iCARE-1300) 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 | 6934175002A0002NG | Class A | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 20b5e93e-fb78-4dc3-bd9d-ae7e29d5451e 61 fields · synced Jun 18, 2026