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Ø1.2*6 mm Mini-Screw

by Proi̇mtech Sağlik Ürünleri̇ Anoni̇m Şi̇rketi̇

Ref BFS12L06Model Ø1.2*6 mm Mini-Screw

Active European Union

CE MDR

Valid until

21 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SZUTEST Konformitätsbewertungsstelle GmbH

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 Number2975-MED-2614201 Date22 May 2026IssuedStatusActive expires 21 May 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2614201 Active

    Quality management system EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    22 May 2026
    Expires
    21 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Bone Fixation Screw
Model / Reference
Ø1.2*6 mm Mini-Screw, BFS12L06
Primary DI / UDI-DI
08681489708919
Basic UDI-DI
86814897probonefixNT
Direct Marketing DI
08681489708919
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020130

Other devices from Proi̇mtech Sağlik Ürünleri̇ Anoni̇m Şi̇rketi̇

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Properties

  • Implantable
  • Sutures

Other properties (12)

  • Sterile: 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