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GeneStream HAI-AMR-8 Assay

by Healgen Scientific Limited Liability Company EUDAMED

Active European Union

Ref CAMR801A-AHG4E

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CAMR801A-AHGPY Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
GeneStream HAI-AMR-8 Assay
Model / Reference
CAMR801A-AHG4E
Primary DI / UDI-DI
D-CAMR801A-AHGPY
Basic UDI-DI
B-CAMR801A-AHGPY
EMDN Code
W0104080607 Nucleic acid identification - manual / automated other resistance markers
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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See all devices from Healgen Scientific Limited Liability Company →

Properties

Show properties
  • 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