STI-6 Assay

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref CSTI601A-AOG4E

EMDN W0105070501

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-CSTI601AP5 Basic UDI-DI	Date11 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: STI-6 Assay
Model / Reference: CSTI601A-AOG4E

Primary DI / UDI-DI: D-CSTI601AP5
Basic UDI-DI: B-CSTI601AP5
EMDN Code: W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - 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-CSTI601AP5|B-CSTI601AP5 61 fields · synced 24 Oct 2026