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Rocker & Hex Wrench

by Li̇gamed Tibbi̇ Malzemeler San. Ve Ti̇c. Ltd. Şti̇. EUDAMED

Active European Union

Ref 12000.INS028

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681087310538 Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

NorwayNorwayIcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Not drawn on the map: Northern Ireland.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
BIOMECH Rocker & Hex Wrench
Model / Reference
12000.INS028
Primary DI / UDI-DI
08681087310538
Basic UDI-DI
B-08681087310538
EMDN Code
L99 Surgical instruments, reusable - other
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015834

Other devices from Li̇gamed Tibbi̇ Malzemeler San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Li̇gamed Tibbi̇ Malzemeler San. Ve Ti̇c. Ltd. Şti̇. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No