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Ortimplant

by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi 1,000+ variants

Ref O5238213

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-08680941119287 Basic UDI-DI 08680941119287UDI-DIDate19 Mar 2024RegisteredStatusActive

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  • Withdrawn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
3,5 Mm Distal Lateral Humerus Ki̇li̇tli̇ Plak Ti̇tanyum 13 Deli̇k Sağ (3,5 Mm Distal Lateral Humerus Locking Plate Titanium 13 Holes Right)
Model / Reference
O5238213
Primary DI / UDI-DI
08680941119287
Basic UDI-DI
B-08680941119287
EMDN Code
P09120501 Osteosynthesis compression plates
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017438

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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