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Bone screw sterile; Ti, cortical, self-tapping, HA 4.5×52 mm

by MEDIN, a.s.

Ref 397129799554SModel Screw

Active European Union

CE MDR

Valid until

31 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number85917126030101SP9 Basic UDI-DI 08591712388484UDI-DIDate2 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-084 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    22 Dec 2025
    Expires
    31 Aug 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Bone screw sterile
Model / Reference
Screw, 397129799554S
Primary DI / UDI-DI
08591712388484
Basic UDI-DI
85917126030101SP9
Direct Marketing DI
08591712388484
EMDN Code
P09120601 Cortical screws
Models / Variants
Device Class
Class IIb
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000012371

Related devices

Category: Orthopaedic bone screw (non-sliding)

Other devices from MEDIN, a.s.

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Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • 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