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Elastics

by Leone S.P.A. 29 variants

Ref K0945-14

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033707065890 Basic UDI-DI 08033707065890UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033707065890 UDI-DI Date4 May 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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 inter-arch elastic band
Device Name
Elastics
Model / Ref / Catalog
K0945-14
Primary DI / UDI-DI
08033707065890
Basic UDI-DI
B-08033707065890
FDA Product Code
ECI
EMDN Code
Q010404 Orthodontic elastics, chains and springs
GMDN Term
Orthodontic inter-arch elastic band
Device Class
Class I
Regulation Number
872.5410
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000005986

Related devices

Category: Orthodontic retainer

Other devices from Leone S.P.A.

See all devices from Leone S.P.A. →

Properties

  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: 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