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Novus

by Zydus MedTech Pvt.Ltd EUDAMED

Active European Union

Ref NV3.5048

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904488688090 Basic UDI-DIDate1 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
Novus Sirolimus Eluting Coronary Stent System
Model / Reference
NV3.5048
Primary DI / UDI-DI
08904488688090
Basic UDI-DI
B-08904488688090
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
IN-MF-000047910
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zydus MedTech Pvt. Ltd.

See all devices from Zydus MedTech Pvt. Ltd. →

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (8)

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