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Neutrophil Gelatinase Associated Lipocalin (NGAL) Quantitative Test Cassette (Q…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD067Model 25 tests/kit
Identity
- Trade Name
- Neutrophil Gelatinase Associated Lipocalin (NGAL) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Device Name
- Neutrophil Gelatinase Associated Lipocalin (NGAL) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMEDGKPD067 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403496 EUDAMED
- Basic UDI-DI
- B-06977698403496 EUDAMED
- EMDN Code
- W0102160901 LIPOCALIN-2 GRANULOCYTE GELATINASE ASSOCIATED - RT & POC 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
Neutrophil Gelatinase Associated Lipocalin (NGAL) Quantitative Test Cassette (Q… by Dezhou Guoke Medical 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-06977698403496 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED fd076b67-5b8b-4f04-b10e-b6ddbfea9976 61 fields · synced Jun 18, 2026