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by Medi̇koki̇m Tibbi̇ Ve Ki̇myevi̇ Malz.san. Ve Ti̇c.a.ş. 9 variants

Ref LHB01

Active European Union

CE MDR

Valid until

29 May 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

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/MDR Number869888147TF03M0339 Basic UDI-DI 08698881472881UDI-DIDate8 Oct 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00068-C Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    30 May 2025
    Expires
    29 May 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Bilek Gergi Kayışı
Model / Reference
LHB01
Primary DI / UDI-DI
08698881472881
Basic UDI-DI
869888147TF03M0339
EMDN Code
M030599 Immobilisation systems and devices - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020142

Other devices from Medi̇koki̇m Tibbi̇ Ve Ki̇myevi̇ Malz.san. Ve Ti̇c.a.ş.

  • Tsm

    Class I

  • Trapad

    Class I

  • Traegermed

    Class I

  • Pulsomed

    Class I

  • Mittmed

    Class I

  • Staendermed

    Class I

See all devices from Medi̇koki̇m Tibbi̇ Ve Ki̇myevi̇ Malz.san. Ve Ti̇c.a.ş. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: 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