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Balloon Catheter

by Hicren (Zhejiang) Medtech Co., Ltd. China EUDAMED

Ref SV211-18DModel SV211-14D, SV211-18D, SV211-22D, SV211-26D, SV211-14SD, SV211-18SD, SV211-22SD, SV211-26SD, SV211-15ZD, SV211-18ZD, SV211-22ZD, SV211-27ZD, SV211-15SZD, SV211-18SZD, SV211-22SZD, SV211-27SZD

EMDN P099002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69362608SV211-DNQ Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Balloon Catheter
Model / Reference
SV211-14D, SV211-18D, SV211-22D, SV211-26D, SV211-14SD, SV211-18SD, SV211-22SD, SV211-26SD, SV211-15ZD, SV211-18ZD, SV211-22ZD, SV211-27ZD, SV211-15SZD, SV211-18SZD, SV211-22SZD, SV211-27SZD
Primary DI / UDI-DI
06936260855484
Basic UDI-DI
69362608SV211-DNQ
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000025999
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hicren (Zhejiang) Medtech Co., Ltd.

See all devices from Hicren (Zhejiang) Medtech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 06936260855484|69362608SV211-DNQ 61 fields · synced 25 Oct 2026