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Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Polymyxin

by Beijing Applied Biological Technologies Co., Ltd. 2 variants

Ref A7388-25T

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974323012382 Basic UDI-DI 06974323012382UDI-DIDate29 Apr 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  • Withdrawn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

Device Name
Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Polymyxin
Model / Reference
A7388-25T
Primary DI / UDI-DI
06974323012382
Basic UDI-DI
B-06974323012382
EMDN Code
W0104080607 Nucleic acid identification - manual / automated other resistance markers
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012338
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Beijing Applied Biological Technologies Co., Ltd.

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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