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Rapid Group A Streptococcus DNA Test

by Healgen Scientific Limited Liability Company EUDAMED

Active European Union

Ref RGAS01-AHG5E/ RGAS01-AHG25E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-81649002RGAS01JKST Basic UDI-DIDate25 May 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  • Withdrawn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
Rapid Group A Streptococcus DNA Test
Model / Reference
RGAS01-AHG5E/ RGAS01-AHG25E
Primary DI / UDI-DI
D-81649002RGAS01JKST
Basic UDI-DI
B-81649002RGAS01JKST
EMDN Code
W0105011103 Strep. a detection by na reagents
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

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

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