Neuron Specific Enolase Chemiluminescence Immunoassay Kit

EUDAMED

Class IVD General (EU MDR)

Ref S2042E-25

by Sansure Biotech Inc.

Identity

Device Name: Neuron Specific Enolase Chemiluminescence Immunoassay Kit EUDAMED
Model / Reference: S2042E-25 EUDAMED

Identifiers

Primary DI / UDI-DI: 06955792739345 EUDAMED
Basic UDI-DI: B-06955792739345 EUDAMED
EMDN Code: W0102039007 NEURON SPECIFIC ENOLASE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

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-06955792739345	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 (1)

EUDAMED a0bdbb1b-f80a-4e8a-9b19-e220bc66b6a1 61 fields · synced Jun 18, 2026