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Extender

by İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş. Türkiye EUDAMED

Ref BTK4060S

EMDN C010402020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-86814100652584U Basic UDI-DIDate7 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Extender Drug-Released PTA 14 BTK Balloon Catheter, 4.0 mm Balloon diameter, 60 mm Balloon lenght,120 cm Catheter lenght
Model / Reference
BTK4060S
Primary DI / UDI-DI
D-86814100652584U
Basic UDI-DI
B-86814100652584U
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000019963

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d527f0d8-3dcd-47c1-8db7-891515fb1222 61 fields · synced 23 Oct 2026