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Balloon Catheter

by Hicren (Zhejiang) Medtech Co., Ltd. 32 variants

Ref SV211-26SModel SV211-14, SV211-18, SV211-22, SV211-26, SV211-14S, SV211-18S, SV211-22S, SV211-26S, SV211-15Z, SV211-18Z, SV211-22Z, SV211-27Z, SV211-15SZ, SV211-18SZ, SV211-22SZ, SV211-27SZ

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69362608SV211S2 Basic UDI-DI 06936260855620UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Balloon Catheter
Model / Reference
SV211-14, SV211-18, SV211-22, SV211-26, SV211-14S, SV211-18S, SV211-22S, SV211-26S, SV211-15Z, SV211-18Z, SV211-22Z, SV211-27Z, SV211-15SZ, SV211-18SZ, SV211-22SZ, SV211-27SZ
Primary DI / UDI-DI
06936260855620
Basic UDI-DI
69362608SV211S2
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class IIa
EU 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

  • 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