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Drt Plus Poli̇aksi̇yel Li̇stezi̇s Vİda 4, 5X35 Mm

by Doratek Medi̇kal Elektri̇k Maki̇na İmalati Turi̇zm İnşaat San. Ve Ti̇c.ltd.şti̇.

Ref PRKY-4535

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-08681190559985 Basic UDI-DI 08681190559985UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Drt Plus Polyaxial Reduction Screw 4,5X35 Mm
Model / Reference
PRKY-4535
Primary DI / UDI-DI
08681190559985
Basic UDI-DI
B-08681190559985
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017744

Other devices from Doratek Medi̇kal Elektri̇k Maki̇na İmalati Turi̇zm İnşaat San. Ve Ti̇c.ltd.şti̇.

See all devices from Doratek Medi̇kal Elektri̇k Maki̇na İmalati Turi̇zm İnşaat San. Ve Ti̇c.ltd.şti̇. →

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No