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tourniquet

by Hengshui Runde Medical Instruments Co., Ltd. EUDAMED

Active European Union

Model RDS12KAC, RDS-12OPP, RDS-12BPP, RDS-12KAB, RDS-12BAB

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697562124RDS12KAC38 Basic UDI-DIDate29 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
tourniquet
Model / Reference
RDS12KAC, RDS-12OPP, RDS-12BPP, RDS-12KAB, RDS-12BAB
Primary DI / UDI-DI
06975621241221, 06975621241276, 06975621241238, 06975621241214, 06975621241252
Basic UDI-DI
697562124RDS12KAC38, 697562124RDS12OPP63, 697562124RDS12BPP42, 697562124RDS12KAB36, 697562124RDS12BABZN
EMDN Code
C90010301 Haemostasis mechanical systems (including single-use tourniquets)
Device Class
Class I
Market of Registration
Poland
Czechia
Belgium
Croatia
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028094
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hengshui Runde Medical Instruments Co., Ltd.

See all devices from Hengshui Runde Medical Instruments Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No