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Strep A Rapid Test (Throat Swab)

by Innovacon, Inc. EUDAMED

Active European Union

Ref IST-501Model 4564849001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00810124272777 Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Strep A Rapid Test (Throat Swab)
Model / Reference
4564849001, IST-501
Primary DI / UDI-DI
00810124272777
Basic UDI-DI
B-00810124272777
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000057104
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Innovacon, Inc.

See all devices from Innovacon, Inc. →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No