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KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

by Jiangsu Medomics Medical Technology Co., Ltd. 3 variants

Ref 211045-01-061

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-211045-01-061C9 Basic UDI-DI D-211045-01-061C9UDI-DIDate13 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
211045-01-061
Primary DI / UDI-DI
D-211045-01-061C9
Basic UDI-DI
B-211045-01-061C9
EMDN Code
W0104080506 Targeted resistance tests - carbapenemase
Device Class
Class IVD General
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000030226
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Jiangsu Medomics Medical Technology Co., Ltd.

See all devices from Jiangsu Medomics Medical Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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