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Orthodontic Tubes

by Leone S.P.A. 718 variants

Ref G8384-32

Orthodontic Tubes (G8384-32) is a device classified as Class IIa in the EU and Class I in the US made by Leone S.P.A., registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI B-08033707064275) and listed in FDA GUDID since 4 Feb 2021 (UDI-DI 08033707064275), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033707064275 Basic UDI-DI 08033707064275UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033707064275 UDI-DI Date4 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08033707064275 registered 15 Apr 2026 Active
  • FDA GUDID UDI-DI 08033707064275 listed 4 Feb 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033707064275
  2. Registered EUDAMED B-08033707064275

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Leone SpA
Generic name
Orthodontic tube
Device name
Orthodontic Tubes
Model / Ref / Catalog
G8384-32
Primary DI / UDI-DI
08033707064275
Basic UDI-DI
B-08033707064275
FDA product code
DZD
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic tube
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000005986

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

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 (21, all answered No)