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Aditek 07.11.3303

by Aditek Do Brasil S/a

Ref 07.11.3303

Aditek 07.11.3303 is a device classified as Class IIa in the EU and Class I in the US made by Aditek Do Brasil S/a, registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI B-07899439249073) and listed in FDA GUDID since 6 Sep 2023 (UDI-DI 07899439249073), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07899439249073 Basic UDI-DI 07899439249073UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899439249073 UDI-DI Date6 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07899439249073 registered 12 Jun 2026 Active
  • FDA GUDID UDI-DI 07899439249073 listed 6 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899439249073
  2. Registered EUDAMED B-07899439249073

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  • Withdrawn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
Niti Retraction Closed Coil Spring 012X030 15mm W/04 EUDAMED
Aditek GUDID
Generic name
Orthodontic spring
Model / reference
07.11.3303
Primary DI / UDI-DI
07899439249073
Basic UDI-DI
B-07899439249073
FDA product code
ECO
EMDN code
Q010405 Orthodontic wires
GMDN term
Orthodontic spring
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Orthodontic spring

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)