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Sterile PTA Balloon Catheter

by Zhejiang Barty Medical Technology Co., Ltd. 352 variants

Ref H100025012014

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 23 Oct 2026. What this means

Overview

The Sterile PTA Balloon Catheter is a medical device designed for the insertion of sterile balloons into blood vessels. This Class IIa device is manufactured by Zhejiang Barty Medical Technology Co., Ltd., a leading manufacturer of medical devices in China. With its advanced technology and robust design, this catheter is used in various medical procedures to treat conditions such as varicose veins, aneurysms, and stenosis. The Sterile PTA Balloon Catheter has received FDA clearance for use in the United States and is available for sale in many countries worldwide.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69277410ZBT0003TF Basic UDI-DI 06927741080587UDI-DIDate23 Oct 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  • Withdrawn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

Model / Reference
H100025012014
Primary DI / UDI-DI
06927741080587
Basic UDI-DI
69277410ZBT0003TF
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000007977
Authorised representative
MedPath GmbH DE-AR-000000087

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from Zhejiang Barty Medical Technology Co., Ltd.

See all devices from Zhejiang Barty Medical Technology 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