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Gallant - Art-01 - Gallant Artikülasyon Kağidi (Düz) 80 Mi̇kron

by Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref ART-01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/MDR Number86818127ART5H Basic UDI-DI 08681812700047UDI-DIDate3 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gallant Artikülasyon Kağidi
Model / Reference
ART-01
Primary DI / UDI-DI
08681812700047
Basic UDI-DI
86818127ART5H
EMDN Code
Q01020201 Articulation papers
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000055098

Other devices from Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

Other properties (13)

  • Sterile: No
  • 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