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Mindray

by Jilin Leading Bio-Engineering Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref 06924222199981Model URS-11MRQ

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06924222199998 Basic UDI-DIDate26 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Reagent Strips for Urinalysis
Model / Reference
URS-11MRQ, 06924222199981
Primary DI / UDI-DI
06924222199998
Basic UDI-DI
B-06924222199998
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000045630
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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