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Wilma SC

by Sahajanand Medical Technologies Limited 204 variants

Ref FGSW250015

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904118360587 Basic UDI-DI 08904118360587UDI-DIDate30 Nov 2022RegisteredStatusActive

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

EstoniaIrelandPolandCzech RepublicSlovakiaHungaryRomaniaBulgariaSpainItalyTürkiyeCroatia
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 12 countries, as listed in EUDAMED:

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

  • Bulgaria since 1 Jan 2015
  • Croatia since 1 Jan 2015
  • Czechia since 1 Jan 2015
  • Estonia since 1 Jan 2019
  • Hungary since 1 Jan 2016
  • Ireland since 1 Jan 2016
  • Italy since 1 Jan 2020
  • Poland since 1 Jan 2015
  • Romania since 1 Jan 2015
  • Slovakia since 1 Jan 2021
  • Spain since 1 Jan 2016
  • Türkiye since 1 Jan 2015

Last checked 30 Oct 2026.

Specification

EUDAMED

Model / Reference
FGSW250015
Primary DI / UDI-DI
08904118360587
Basic UDI-DI
B-08904118360587
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
IN-MF-000016582
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sahajanand Medical Technologies Limited

See all devices from Sahajanand Medical Technologies Limited →

Properties

  • Sterile

Other properties (10)

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