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Flowty

by Zhejiang Barty Medical Technology Co., Ltd. China EUDAMED

Ref G3.50-26

EMDN C010401020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69277410ZBT0002TD Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0049 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2292
    Issued
    24 Jul 2026
    Expires
    23 Jul 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sterile Paclitaxel-Eluting PTCA Balloon Catheter
Model / Reference
G3.50-26
Primary DI / UDI-DI
06941704347012
Basic UDI-DI
69277410ZBT0002TD
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

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

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

See all devices from Zhejiang Barty Medical Technology 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 06941704347012|69277410ZBT0002TD 61 fields · synced 24 Oct 2026