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Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetr…
EUDAMEDClass IVD General (EU MDR)
Ref 3011568Model R1: 1x30mL, R2: 1x10mL, Calibration sample: 5x1mL, Control: 2x1mLRef 3012921Model R1: 1x30mL, R2: 1x10mLRef 3021560
Identity
- Trade Name
- Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay) EUDAMED
- Device Name
- Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- R1: 1x30mL, R2: 1x10mL, Calibration sample: 5x1mL, Control: 2x1mL EUDAMED3011568 EUDAMEDR1: 1x30mL, R2: 1x10mL EUDAMED3012921 EUDAMED3021560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246661 EUDAMED06942202259838 EUDAMED06925794593818 EUDAMED
- Basic UDI-DI
- B-06942202246661 EUDAMEDB-06942202259838 EUDAMEDB-06925794593818 EUDAMED
- EMDN Code
- W0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
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
Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetr… by Dirui Industrial 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-06942202246661 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 7382e857-4445-48b2-96a4-b13f02acf706 61 fields · synced Sep 18, 2026
- EUDAMED 65bdbdd2-6980-48e4-b461-4c04e2b40bcb 61 fields · synced May 17, 2026
- EUDAMED 5027ad72-ca8e-4be3-8d90-49052421ad26 61 fields · synced Sep 18, 2026