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Slx-121
EUDAMEDClass IVD General (EU MDR)
Ref 3N001DDModel SLX-121 Lipid and Blood Glucose Analyzer
Identity
- Trade Name
- SLX-121 EUDAMED
- Device Name
- Lipid and Blood Glucose Monitoring System EUDAMED
- Model / Reference
- SLX-121 Lipid and Blood Glucose Analyzer EUDAMED3N001DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175039890 EUDAMED
- Basic UDI-DI
- B-06934175039890 EUDAMED
- EMDN Code
- W020106019099 VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal 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
Yes
EUDAMED
Slx-121 by Changsha Sinocare Inc. — 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-06934175039890 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c4ed5d05-6f64-4e9e-95e7-8ec921b17935 61 fields · synced Jun 19, 2026