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Neuron Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitRef 25 Tests/Kit
Identity
- Trade Name
- Neuron Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Neuron Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED25 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813098 EUDAMED06974986814286 EUDAMED
- Basic UDI-DI
- B-06974986813098 EUDAMEDB-06974986814286 EUDAMED
- EMDN Code
- W0102039007 NEURON SPECIFIC ENOLASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Neuron Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed…
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-06974986813098 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d65d3eb7-f501-4d9e-b96f-a88e4702aab5 61 fields · synced Oct 6, 2026
- EUDAMED f0e610f5-18ab-4d48-8da2-2e9c87268a27 61 fields · synced May 17, 2026