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Aditek 09.16.0395

by Aditek Do Brasil S/a

Ref 09.16.0395

Aditek 09.16.0395 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 15 Oct 2026 (Basic UDI-DI B-07899439270428) and listed in FDA GUDID since 15 Jan 2025 (UDI-DI 07899439270428), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07899439270428 Basic UDI-DI 07899439270428UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899439270428 UDI-DI Date15 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07899439270428 registered 15 Oct 2026 Active
  • FDA GUDID UDI-DI 07899439270428 listed 15 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899439270428
  2. Registered EUDAMED B-07899439270428

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  • Withdrawn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
Thermal Niti Archwire Europa Upper 019X025 W/10 EUDAMED
Aditek GUDID
Generic name
Orthodontic wire
Model / reference
09.16.0395
Primary DI / UDI-DI
07899439270428
Basic UDI-DI
B-07899439270428
FDA product code
DZC
EMDN code
Q010405 Orthodontic wires
GMDN term
Orthodontic wire
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 wire

Similar devices in this category

Other devices filed under ORTHODONTIC WIRES.

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Properties

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