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Balloon dilatation catheter

by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. 278 variants

Ref 045020050HModel 040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697174170BDC000188 Basic UDI-DI 06971741703861UDI-DIDate31 Dec 2025RegisteredStatusActive

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  • Withdrawn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 dilatation catheter
Model / Reference
040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC, 045020050H
Primary DI / UDI-DI
06971741703861
Basic UDI-DI
697174170BDC000188
Direct Marketing DI
06971741703861
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000037464
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.

See all devices from Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. →

Properties

  • Sterile
  • Reprocessed

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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