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Vivo Isar

by Translumina Therapeutics Private Limited India EUDAMED

Ref VISR3528Model Polymer Free Sirolimus Eluting Coronary Stent System-L605 Cobalt Chromium (28 X 3.50 mm)

EMDN P070402010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904271621556 Basic UDI-DIDate14 Feb 2026RegisteredStatusActive

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 22 Oct 2026

Model / Reference
Polymer Free Sirolimus Eluting Coronary Stent System-L605 Cobalt Chromium (28 X 3.50 mm), VISR3528
Primary DI / UDI-DI
08904271621556
Basic UDI-DI
B-08904271621556
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED ccc632ee-1cf6-4095-ae9f-0b89d9bec911 61 fields · synced 22 Oct 2026