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Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Imm…
EUDAMEDClass IVD General (EU MDR)
Ref 81H160TSCRef 81H40TSC
Identity
- Trade Name
- Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 81H160TSC EUDAMED81H40TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-81H160TSC9N EUDAMEDD-81H40TSCT7 EUDAMED
- Basic UDI-DI
- B-81H160TSC9N EUDAMEDB-81H40TSCT7 EUDAMED
- EMDN Code
- W0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) 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) Assay Kit (Latex-enhanced Imm… by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in…
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-81H160TSC9N | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 47498846-1f00-4506-ac0d-45b7521a3437 61 fields · synced Oct 6, 2026
- EUDAMED 425670db-3b1b-4c18-a1e2-2d036ccd86f4 61 fields · synced May 18, 2026