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Dunitech

by Oliga Makina Elektronik İthalat İhracat Sanayi ve Ticaret Limited Şirketi 53 variants

Ref NAVY-C-11-360, NAVY-11-001, CORS-05-065, NAVY-13-000, DCLS-011-075, DCLS-011-090, NITE-11-015, CORS-05-085, NAVY-C-10-340, NAVY-C-13-400, NITE-11-000, NITE-C-09-375, NAVY-C-12-300, CORS-05-075, NAVY-C-11-440, NITE-10-001, NAVY-C-10-320, DCLS-011-095, NITE-C-10-360, NAVY-C-10-400, CORS-05-050, CORS-05-070, NEON-125-10-36R, NAVY-C-13-440, NAVY-C-13-340, NAVY-C-13-300, DCPN-08-001, NITE-C-09-315, CORS-05-120, NEON-155-010, CORS-05-040, NEON-125-11-34L, DCLS-011-105, NAVY-C-13-460, NITE-C-11-315, NITE-C-11-375, NAVY-C-10-420, NEON-125-11-38R, NEON-125-11-30L, CORS-05-030, NAVY-C-10-280, NEON-125-11-32L, NITE-C-10-285, NAVY-C-10-460, DCLS-011-080, NAVY-C-10-380, NAVY-13-010, DCLS-011-085, NAVY-C-13-360, CORS-05-035, CORS-05-045

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681124119315 Basic UDI-DI Date14 May 2025RegisteredStatusActive

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  • Withdrawn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
NAIL 11mmx360mm (Ti)
DISTAL END CAP 11mm (FLUSH) (Ti)
SCREW 05mmx65mm (Ti)
PROXIMAL END CAP 00mm (FLUSH) (Ti)
LAG SCREW 75mm (Ti)
LAG SCREW 90mm (Ti)
PROXIMAL END CAP 15mm (Ti)
SCREW 05mmx85mm (Ti)
NAIL 10mmx340mm (Ti)
NAIL 13mmx400mm (Ti)
NAIL 09mmx375mm (Ti)
NAIL 12mmx300mm (Ti)
SCREW 05mmx75mm (Ti)
NAIL 11mmx440mm (Ti)
DISTAL END CAP 10mm (FLUSH) (Ti)
NAIL 10mmx320mm (Ti)
LAG SCREW 95mm (Ti)
NAIL 10mmx360mm (Ti)
NAIL 10mmx400mm (Ti)
SCREW 05mmx50mm (Ti)
SCREW 05mmx70mm (Ti)
PROXIMAL FEMORAL NAIL 360 mm RIGHT (Ti)
NAIL 13mmx440mm (Ti)
NAIL 13mmx340mm (Ti)
NAIL 13mmx300mm (Ti)
PFN SLIDING BOLT RECON SCREW 4.57mm (Ti)
NAIL 09mmx315mm (Ti)
SCREW 05mmx120mm (Ti)
PROXIMAL END CAP 10mm (Ti)
SCREW 05mmx40mm (Ti)
PROXIMAL FEMORAL NAIL 340 mm LEFT (Ti)
LAG SCREW 105mm (Ti)
NAIL 13mmx460mm (Ti)
NAIL 11mmx315mm (Ti)
NAIL 11mmx375mm (Ti)
NAIL 10mmx420mm (Ti)
PROXIMAL FEMORAL NAIL 380 mm RIGHT (Ti)
PROXIMAL FEMORAL NAIL 300 mm LEFT (Ti)
SCREW 05mmx30mm (Ti)
NAIL 10mmx280mm (Ti)
PROXIMAL FEMORAL NAIL 320 mm LEFT (Ti)
NAIL 10mmx285mm (Ti)
NAIL 10mmx460mm (Ti)
LAG SCREW 80mm (Ti)
NAIL 10mmx380mm (Ti)
LAG SCREW 85mm (Ti)
NAIL 13mmx360mm (Ti)
SCREW 05mmx35mm (Ti)
SCREW 05mmx45mm (Ti)
Model / Reference
NAVY-C-11-360, NAVY-11-001, CORS-05-065, NAVY-13-000, DCLS-011-075, DCLS-011-090, NITE-11-015, CORS-05-085, NAVY-C-10-340, NAVY-C-13-400, NITE-11-000, NITE-C-09-375, NAVY-C-12-300, CORS-05-075, NAVY-C-11-440, NITE-10-001, NAVY-C-10-320, DCLS-011-095, NITE-C-10-360, NAVY-C-10-400, CORS-05-050, CORS-05-070, NEON-125-10-36R, NAVY-C-13-440, NAVY-C-13-340, NAVY-C-13-300, DCPN-08-001, NITE-C-09-315, CORS-05-120, NEON-155-010, CORS-05-040, NEON-125-11-34L, DCLS-011-105, NAVY-C-13-460, NITE-C-11-315, NITE-C-11-375, NAVY-C-10-420, NEON-125-11-38R, NEON-125-11-30L, CORS-05-030, NAVY-C-10-280, NEON-125-11-32L, NITE-C-10-285, NAVY-C-10-460, DCLS-011-080, NAVY-C-10-380, NAVY-13-010, DCLS-011-085, NAVY-C-13-360, CORS-05-035, CORS-05-045
Primary DI / UDI-DI
08681124119315, 08681124119902, 08681124120076, 08681124119858, 08681124119070, 08681124119100, 08681124119940, 08681124120113, 08681124119209, 08681124119537, 08681124119919, 08681124119643, 08681124119384, 08681124120090, 08681124119353, 08681124119964, 08681124119193, 08681124119117, 08681124119711, 08681124119230, 08681124120045, 08681124120083, 08681124118998, 08681124119551, 08681124119506, 08681124119483, 08681124120427, 08681124119605, 08681124120182, 08681124119834, 08681124120021, 08681124118967, 08681124119131, 08681124119568, 08681124119766, 08681124119803, 08681124119247, 08681124119018, 08681124118929, 08681124120007, 08681124119179, 08681124118943, 08681124119667, 08681124119261, 08681124119087, 08681124119223, 08681124119872, 08681124119094, 08681124119513, 08681124120014, 08681124120038
Basic UDI-DI
B-08681124119315, B-08681124119902, B-08681124120076, B-08681124119858, B-08681124119070, B-08681124119100, B-08681124119940, B-08681124120113, B-08681124119209, B-08681124119537, B-08681124119919, B-08681124119643, B-08681124119384, B-08681124120090, B-08681124119353, B-08681124119964, B-08681124119193, B-08681124119117, B-08681124119711, B-08681124119230, B-08681124120045, B-08681124120083, B-08681124118998, B-08681124119551, B-08681124119506, B-08681124119483, B-08681124120427, B-08681124119605, B-08681124120182, B-08681124119834, B-08681124120021, B-08681124118967, B-08681124119131, B-08681124119568, B-08681124119766, B-08681124119803, B-08681124119247, B-08681124119018, B-08681124118929, B-08681124120007, B-08681124119179, B-08681124118943, B-08681124119667, B-08681124119261, B-08681124119087, B-08681124119223, B-08681124119872, B-08681124119094, B-08681124119513, B-08681124120014, B-08681124120038
EMDN Code
P09120201, P09120604
Device Class
Class IIb
EU market of registration
Türkiye
Sweden

Manufacturer details

EUDAMED SRN
TR-MF-000022601

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

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Properties

  • Sterile YesEUDAMEDNoEUDAMED
  • Implantable

Other properties (9)

  • 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