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Neutrophil Gelatinase Associated Lipocalin Rapid Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref 25Tests/Kit
Identity
- Device Name
- Neutrophil Gelatinase Associated Lipocalin Rapid Test Kit (FIA) EUDAMED
- Model / Reference
- 25Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970664752017 EUDAMED
- Basic UDI-DI
- B-06970664752017 EUDAMED
- EMDN Code
- W0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Neutrophil Gelatinase Associated Lipocalin Rapid Test Kit (FIA) by Beijing Kewei Clinical Diagnostic Reagent Inc — 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-06970664752017 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Kewei Clinical Diagnostic Reagent Inc
- EUDAMED SRN
- CN-MF-000019125
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d2cb56ae-d440-4ad6-9846-275558a24b2e 61 fields · synced Jun 18, 2026