← Back to catalogue
Neuron Specific Enolase Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2042E-100Ref S2042E-200Ref S2042E-50Ref S2042E-75
Identity
- Device Name
- Neuron Specific Enolase Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2042E-100 EUDAMEDS2042E-200 EUDAMEDS2042E-50 EUDAMEDS2042E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739376 EUDAMED06955792739390 EUDAMED06955792739352 EUDAMED06955792739369 EUDAMED
- Basic UDI-DI
- B-06955792739376 EUDAMEDB-06955792739390 EUDAMEDB-06955792739352 EUDAMEDB-06955792739369 EUDAMED
- EMDN Code
- W0102039007 NEURON SPECIFIC ENOLASE 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
Neuron Specific Enolase Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06955792739376 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED d27f7268-dd57-4593-b468-a9425c2c0ed4 61 fields · synced Aug 1, 2026
- EUDAMED 8840c040-9f43-4c31-9c67-30a177a8a749 61 fields · synced May 17, 2026
- EUDAMED 7d8765f9-199a-48dd-ab01-4fb55b60ddb1 61 fields · synced May 17, 2026
- EUDAMED ec375ffd-c364-4fcb-9cd1-779495ba52e0 61 fields · synced May 17, 2026