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D-dimer Assay Kit (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0320303504Model 100Tests/Kit
Identity
- Trade Name
- D-dimer Assay Kit (Lateral Flow Immunoassay) EUDAMEDD-dimer Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- D-dimer Assay Kit (Lateral Flow Immunoassay) EUDAMEDD-dimer Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED0320303504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062877 EUDAMED
- Basic UDI-DI
- B-06975984062877 EUDAMED69703416803203001HF EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
D-dimer Assay Kit (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975984062877 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984062877 | 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 (2)
- EUDAMED 1b175b6e-a98a-4445-ac14-bcf16b1ba76c 61 fields · synced Jul 17, 2026
- EUDAMED a2a27bda-f37c-45bf-bfe3-a7d8ef006f61 61 fields · synced May 18, 2026