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Sterile PTA Balloon Catheter

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

Ref H130040006035D

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

Overview

The Sterile PTA Balloon Catheter is a medical device designed for the minimally invasive placement of stents in coronary arteries. This device features a unique balloon architecture that allows for precise and effective delivery of the stent material, resulting in improved patient outcomes.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69277410ZBT0003TF Basic UDI-DI 06927741086305UDI-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  • Withdrawn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
H130040006035D
Primary DI / UDI-DI
06927741086305
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