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Vivo Isar

by Translumina Therapeutics Private Limited EUDAMED

Active European Union

Ref VISR2016Model Polymer Free Sirolimus Eluting Coronary Stent System-L605 Cobalt Chromium (16 X 2.00 mm)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904271621037 Basic UDI-DIDate9 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Polymer Free Sirolimus Eluting Coronary Stent System-L605 Cobalt Chromium (16 X 2.00 mm), VISR2016
Primary DI / UDI-DI
08904271621037
Basic UDI-DI
B-08904271621037
EMDN Code
P070402010302 Coronary drug eluting stents (des) without polymers
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000047911
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Translumina Therapeutics Private Limited

See all devices from Translumina Therapeutics Private Limited →

Properties

  • Sterile
  • Implantable
  • Administering Medicine
  • Incorporates Medicinal Product

Other properties (7)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No