← Back to catalogue
Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0320301302Model 50 Tests/KitRef 0320301303Model 100Tests/Kit
Identity
- Trade Name
- Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED0320301302 EUDAMED100Tests/Kit EUDAMED0320301303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067841 EUDAMED06975984067858 EUDAMED
- Basic UDI-DI
- B-06975984067841 EUDAMEDB-06975984067858 EUDAMED
- EMDN Code
- W0102019008 CYSTATIN C EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975984067841 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c4c05050-714e-4472-9fb1-10812c6115a8 61 fields · synced Jul 13, 2026
- EUDAMED 17c56693-88b3-4167-a18f-0d75863d0cb8 61 fields · synced May 17, 2026