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Treat Sirolimus Eluting Coronary Stent System

by Purple MicroPort Cardiovascular Private Limited 72 variants

Ref CC2.1 4.0008

Active European Union

CE MDD

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/MDD NumberB-08904121810079 Basic UDI-DI 08904121810079UDI-DIDate22 May 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
CC2.1 4.0008
Primary DI / UDI-DI
08904121810079
Basic UDI-DI
B-08904121810079
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
IN-MF-000028173
Authorised representative
Obelis s.a. BE-AR-000000106

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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