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Procalcitonin (PCT) Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 745001Model 25 Tests/KitRef 0320303201Model 10 Tests/KitRef 0320303202Model 50 Tests/KitRef 0320303203Model 100Tests/Kit
Identity
- Trade Name
- Procalcitonin (PCT) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Procalcitonin (PCT) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED745001 EUDAMED10 Tests/Kit EUDAMED0320303201 EUDAMED50 Tests/Kit EUDAMED0320303202 EUDAMED100Tests/Kit EUDAMED0320303203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341681517 EUDAMED06975984067742 EUDAMED06975984067759 EUDAMED06975984067766 EUDAMED
- Basic UDI-DI
- B-06970341681517 EUDAMEDB-06975984067742 EUDAMEDB-06975984067759 EUDAMEDB-06975984067766 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN 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
Procalcitonin (PCT) 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-06970341681517 | 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 6d581deb-9887-44f0-a403-0bc2069b17cd 61 fields · synced Jul 21, 2026
- EUDAMED 4a7271db-7c5d-407d-b409-1accf736cd19 61 fields · synced May 17, 2026
- EUDAMED 06241f19-97da-4336-b6dd-cd5cd1f5a6c0 61 fields · synced May 17, 2026
- EUDAMED 256f212f-3cdd-4a74-bffa-e693cd58c22a 61 fields · synced May 18, 2026