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Galaxy CT/NG/UU Assay

by Igenesis(Shanghai)Co., Ltd.

Ref 106-0137-01Model 12 reactions/kit

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697544758CT/NG/UUCJ Basic UDI-DI 06975447582164UDI-DIDate6 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Chlamydia trachomatis/Neisseria gonorrhoeae/Ureaplasma urealyticum Diagnostic Kit (PCR-Fluorescence)
Model / Reference
12 reactions/kit, 106-0137-01
Primary DI / UDI-DI
06975447582164
Basic UDI-DI
697544758CT/NG/UUCJ
Direct Marketing DI
06975447582164
EMDN Code
W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex na reagents
Device Class
Class C
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001552
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

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