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Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoass…
EUDAMEDClass IVD General (EU MDR)
Ref 0320303601Model 10 Tests/KitRef 0320303602Model 50 Tests/KitRef 745002Model 25 Tests/KitRef 0320303603Model 100Tests/Kit
Identity
- Trade Name
- Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 10 Tests/Kit EUDAMED0320303601 EUDAMED50 Tests/Kit EUDAMED0320303602 EUDAMED25 Tests/Kit EUDAMED745002 EUDAMED100Tests/Kit EUDAMED0320303603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067711 EUDAMED06975984067728 EUDAMED06978139075760 EUDAMED06975984067735 EUDAMED
- Basic UDI-DI
- B-06975984067711 EUDAMEDB-06975984067728 EUDAMEDB-06978139075760 EUDAMEDB-06975984067735 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN 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
Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoass… by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD…
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-06975984067711 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED a8636cdc-7f0b-4452-9e66-f93bf1961b6a 61 fields · synced Sep 18, 2026
- EUDAMED 1105c8a0-b209-4e59-acf0-9a8390efd698 61 fields · synced May 17, 2026
- EUDAMED a084a88d-db15-4547-9a75-c75779fc6ccd 61 fields · synced May 18, 2026
- EUDAMED 85adfae8-c8be-4c4d-bccf-493f63a79859 61 fields · synced May 18, 2026