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Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0201002841Model 10 tests/kit
Identity
- Trade Name
- Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 10 tests/kit EUDAMED0201002841 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971140521103 EUDAMED
- Basic UDI-DI
- B-06971140521103 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) by Beijing Kinghawk Pharmaceutical 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-06971140521103 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Kinghawk Pharmaceutical CO., Ltd
- EUDAMED SRN
- CN-MF-000052726
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 3c1039ae-d861-4663-9683-cf8fc0528910 61 fields · synced Jul 10, 2026