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Aditek 04.01.2295

by Aditek Do Brasil S/a

Ref 04.01.2295

Aditek 04.01.2295 is an orthodontic metal band (EU MDD Class IIa; FDA Class I; FDA product code ECI, Band, Elastic, Orthodontic) made by Aditek Do Brasil S/a, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-07899439233393) and listed in FDA GUDID since 4 Sep 2023 (UDI-DI 07899439233393), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07899439233393 Basic UDI-DI 07899439233393UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899439233393 UDI-DI Date4 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07899439233393 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 07899439233393 listed 4 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899439233393
  2. Registered EUDAMED B-07899439233393

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  • Withdrawn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
Molar Band Ul 29,5 W/10 EUDAMED
Aditek GUDID
Generic name
Orthodontic metal band
Model / reference
04.01.2295
Primary DI / UDI-DI
07899439233393
Basic UDI-DI
B-07899439233393
FDA product code
ECI
EMDN code
Q010402 Orthodontic bands
GMDN term
Orthodontic metal band
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

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.

Related devices

Category: Orthodontic metal band

Similar devices in this category

Other devices filed under ORTHODONTIC BANDS.

Other devices from Aditek Do Brasil S/a

See all devices from Aditek Do Brasil S/a →

Properties

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