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Single-patient-use instruments and accessories

by Leone S.P.A. 57 variants

Ref 156-4810-54

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

Single-patient-use instruments and accessories are medical devices designed for precise measurement and analysis of human tissues. These instruments are typically used in laboratory settings, allowing for the collection and processing of complex biological samples. With a focus on high accuracy and reliability, Single-patient-use instruments and accessories are essential tools for medical professionals seeking to make informed decisions about patient care.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number080337070TDI003VK Basic UDI-DI 08033707083221UDI-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  • Withdrawn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
156-4810-54
Primary DI / UDI-DI
08033707083221
Basic UDI-DI
080337070TDI003VK
EMDN Code
Q010399 Surgical dental 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