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Qingli

by Zhejiang QL Biotech Co., Ltd. EUDAMED

Active European Union

Ref IST502, IST-502Model IST-501 (Strip) / IST-502 (Device)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-26976081910010 Basic UDI-DIDate20 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-26976081910010 Basic UDI-DIDate20 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

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 (Swab)
Model / Reference
IST-501 (Strip) / IST-502 (Device), IST502, IST-502
Primary DI / UDI-DI
26976081910010
Basic UDI-DI
B-26976081910010, 6976081918100000120VW
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class IVD General
Class B
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
  • Professional Testing

Other properties (8)

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