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Tresfort™ 35 Pro PTA Balloon Catheter

by APT Medical Inc. 224 variants

Ref 27608200Model Balloon diameter(3-12.0mm), Balloon length(20-200mm), Effective length(40-135cm)

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 Number69420753NC-35PTA276HN Basic UDI-DI 06942075379862UDI-DIDate4 Sep 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  • Withdrawn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

Model / Reference
Balloon diameter(3-12.0mm), Balloon length(20-200mm), Effective length(40-135cm), 27608200
Primary DI / UDI-DI
06942075379862
Basic UDI-DI
69420753NC-35PTA276HN
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000009046
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from APT Medical Inc.

See all devices from APT Medical Inc. →

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