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Single-patient-use instruments and accessories

by Leone S.P.A. EUDAMEDGUDID

Active European Union

Ref F4900-06

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number080337070TDI003VK Basic UDI-DIDate5 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08033707078005 UDI-DIDate4 May 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Leone SpA
Generic Name
Orthodontic pliers
Device Name
Single-patient-use instruments and accessories
Model / Ref / Catalog
F4900-06
Primary DI / UDI-DI
08033707078005
Basic UDI-DI
080337070TDI003VK
FDA Product Code
JEX
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic pliers
Device Class
Class I
Regulation Number
872.4565
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
IT-MF-000005986

Other devices from Leone S.P.A.

See all devices from Leone S.P.A. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No