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Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2157E-50Ref S2158E-150Ref S2157E-100Ref S2157E-75Ref S2157E-25Ref S2158E-75Ref S2158E-100Ref S2158E-50
Identity
- Device Name
- Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2157E-50 EUDAMEDS2158E-150 EUDAMEDS2157E-100 EUDAMEDS2157E-75 EUDAMEDS2157E-25 EUDAMEDS2158E-75 EUDAMEDS2158E-100 EUDAMEDS2158E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743212 EUDAMED06955792743304 EUDAMED06955792743236 EUDAMED06955792743229 EUDAMED06955792743205 EUDAMED06955792743281 EUDAMED06955792743298 EUDAMED06955792743274 EUDAMED
- Basic UDI-DI
- B-06955792743212 EUDAMEDB-06955792743304 EUDAMEDB-06955792743236 EUDAMEDB-06955792743229 EUDAMEDB-06955792743205 EUDAMEDB-06955792743281 EUDAMEDB-06955792743298 EUDAMEDB-06955792743274 EUDAMED
- EMDN Code
- W0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech 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-06955792743212 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED ac3e0274-3ffc-4ac1-aff3-c2e1c3379468 61 fields · synced Oct 6, 2026
- EUDAMED f880ef7a-af15-4ab5-9ae1-652e0d539cb8 61 fields · synced May 17, 2026
- EUDAMED 2e2d7399-f37a-44ff-a51b-3635492fa3d8 61 fields · synced May 18, 2026
- EUDAMED a9f1d745-2146-4db9-bda3-3fded6b58ac7 61 fields · synced May 18, 2026
- EUDAMED bcca170f-4268-4ff4-96d0-b28189380c20 61 fields · synced May 18, 2026
- EUDAMED 0e574667-38ae-43a5-9043-988b39ce3cea 61 fields · synced May 18, 2026
- EUDAMED 72d7ec2e-30f7-40a7-8e3b-a18c71408713 61 fields · synced May 18, 2026
- EUDAMED 20109508-44b5-44d6-819f-71d5bba11ed2 61 fields · synced May 19, 2026