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Mitigator

by Envision Scientific Pvt. Ltd. 74 variants

Ref EMI40024

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08906061902081 Basic UDI-DIDate7 Aug 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDD Withdrawn

EU market availability

Not listed: EUDAMED names no country where this device is made available.

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

Last checked 24 Oct 2026.

Specification

EUDAMED

Device Name
Mitigator Sirolimus Eluting Coronary Stent System
Model / Reference
EMI40024
Primary DI / UDI-DI
08906061902081
Basic UDI-DI
B-08906061902081
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III

Manufacturer details

EUDAMED SRN
IN-MF-000013319
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Envision Scientific Pvt. Ltd.

See all devices from Envision Scientific Pvt. Ltd. →

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