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Tm-Linefix Fixation Guide Ve Nitinol Wire MR Compatible Nonsterile

by Tulpar Tıbbi Ürünler İthalat İhracat Sanayi ve Ticaret L.T.D Ş.T.İ

Ref TM00397130Model Guide Wires

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681596114214 Basic UDI-DI 08681596114214UDI-DIDate28 Mar 2023RegisteredStatusActive

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  • Withdrawn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
Guide Wires, TM00397130
Primary DI / UDI-DI
08681596114214
Basic UDI-DI
B-08681596114214
EMDN Code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022604

Related devices

Category: General internal orthopaedic fixation system implantation kit

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Properties

  • Sterile
  • Administering Medicine

Other properties (9)

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