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Strep A Rapid Test Device

by Zhejiang QL Biotech Co., Ltd. EUDAMED

Active European Union

Ref IST-502s

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6976081918000000472W9 Basic UDI-DIDate24 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6210573CE01 Issued

    Quality management system EU IVDR

    Notified body
    Notified body 0344
    Issued
    19 Jan 2026
    Expires
    1 Jan 2031
  • 6210573TD01 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 0344
    Issued
    19 Jan 2026
    Expires
    1 Jan 2031

Specification

EUDAMED

Device Name
Strep A Rapid Test (Swab)
Model / Reference
IST-502s
Primary DI / UDI-DI
06976081910016, 16976081910013, 56976081910011
Basic UDI-DI
6976081918000000472W9
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000034990
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang QL Biotech Co., Ltd.

See all devices from Zhejiang QL Biotech Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No