Skip to content

Tibia impaktor

by Sanatmetal Ortopédiai és Traumatológiai Eszközöket Gyártó Kft.

Ref 429200021

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Overview

The Tibia Impaktor is a cutting-edge medical device designed for precise and effective treatment of osteoarthritis, providing personalized care to patients. Our innovative technology enables minimally invasive surgery with superior results, improving patient outcomes and satisfaction.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5996527653IMPEXTNSTSZ Basic UDI-DI 05996527016769UDI-DIDate3 Jan 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Impactor and Extraktor
Model / Reference
429200021
Primary DI / UDI-DI
05996527016769
Basic UDI-DI
5996527653IMPEXTNSTSZ
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
Device Class
Class I
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000006772

Other devices from Sanatmetal Ortopédiai és Traumatológiai Eszközöket Gyártó Kft.

See all devices from Sanatmetal Ortopédiai és Traumatológiai Eszközöket Gyártó Kft. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: 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