CNS-8 Assay

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref CCNS801A-AOG4E

EMDN W0105070505

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-CCNS801A-AOGU7 Basic UDI-DI	Date14 Sep 2026Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: CNS-8 Assay
Model / Reference: CCNS801A-AOG4E

Primary DI / UDI-DI: D-CCNS801A-AOGU7
Basic UDI-DI: B-CCNS801A-AOGU7
EMDN Code: W0105070505 Meningitis / encephalitis infections - multiplex na reagents

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000017965
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties & raw data

Show properties, registry sources and raw records

Microbial Substances
Reagent
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED D-CCNS801A-AOGU7|B-CCNS801A-AOGU7 61 fields · synced 24 Oct 2026