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Blood Culture Pathogen and Antimicrobial Resistance Gene (G-&AMR) Nucleic Acid Detection Kit 1.1

by Shenzhen Chenghui Medical Technology Co., Ltd.

Ref CHE-BCIP27-101

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-06975529962716 Basic UDI-DI 06975529962716UDI-DIDate24 Sep 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  • Withdrawn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
Blood Culture Pathogen and Antimicrobial Resistance Gene (G-&AMR) Nucleic Acid Detection Kit 1.1
Model / Reference
CHE-BCIP27-101
Primary DI / UDI-DI
06975529962716
Basic UDI-DI
B-06975529962716
EMDN Code
W0105070202 Blood stream infection/sepsis (bacteria & fungi) - multiplex na reagents
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000046638
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

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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