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Wilma NC

by Sahajanand Medical Technologies Limited 252 variants

Ref FGNW350021

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-08904118364042 Basic UDI-DI 08904118364042UDI-DIDate8 Aug 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

EstoniaHungaryRomaniaItalyTürkiyeCroatia
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 6 countries, as listed in EUDAMED:

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

  • Croatia since 1 Jan 2018
  • Estonia since 1 Jan 2018
  • Hungary since 1 Jan 2019
  • Italy since 1 Jan 2020
  • Romania since 1 Jan 2019
  • Türkiye since 1 Jan 2018

Last checked 29 Oct 2026.

Specification

EUDAMED

Model / Reference
FGNW350021
Primary DI / UDI-DI
08904118364042
Basic UDI-DI
B-08904118364042
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Croatia

Manufacturer details

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

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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