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Neuron-Specific Enolase assay (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 7C09V1-B-EU, 7C09U1-B-EU, 7C09P1-B-EU
Identity
- Trade Name
- Neuron-Specific Enolase assay (CLIA) EUDAMED
- Device Name
- Neuron-Specific Enolase assay (CLIA) EUDAMED
- Model / Reference
- 7C09V1-B-EU, 7C09U1-B-EU, 7C09P1-B-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-7C09DU EUDAMED
- Basic UDI-DI
- B-7C09DU EUDAMED
- EMDN Code
- W0102039007 NEURON SPECIFIC ENOLASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
Neuron-Specific Enolase assay (CLIA) by Xiamen Boson Biotech Co., Ltd. — 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-7C09DU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED c2e3d6e5-93f2-431c-8417-84bc69a5a2ad 61 fields · synced Jul 18, 2026
- EUDAMED c2e3d6e5-93f2-431c-8417-84bc69a5a2ad-1 61 fields · synced Jun 10, 2026