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Single-patient-use instruments and accessories

by Leone S.P.A. 57 variants

Ref 141-4105-55

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 24 Oct 2026. What this means

Overview

Our Single-patient-use instruments and accessories device is designed for precision and reliability in a variety of medical settings. Developed with safety and efficacy in mind, this cutting-edge device offers exceptional performance and ease of use. Explore our comprehensive suite of features and benefits to learn more.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number080337070TDI003VK Basic UDI-DI 08033707073444UDI-DIDate5 Dec 2022RegisteredStatusActive

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  • Withdrawn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

Model / Reference
141-4105-55
Primary DI / UDI-DI
08033707073444
Basic UDI-DI
080337070TDI003VK
EMDN Code
Q010299 Prosthetic dentistry devices - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005986

Other devices from Leone S.P.A.

See all devices from Leone S.P.A. →

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