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BioLingual® -270-0430

by Forestadent Bernhard Förster GmbH

Part of a family of 251 devices: see the family page

Ref -270-0430

BioLingual® -270-0430 is a device classified as Class IIa in the EU and Class I in the US made by Forestadent Bernhard Förster GmbH, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI ++EFOR020106DL) and listed in FDA GUDID since 24 Sep 2019 (UDI-DI EFOR27004301), active as of 24 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number++EFOR020106DL Basic UDI-DI EFOR27004301UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEFOR27004301 UDI-DI Date24 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++EFOR020106DL registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI EFOR27004301 listed 24 Sep 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EFOR27004301
  2. Registered EUDAMED ++EFOR020106DL

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
BioLingual®
Generic name
Orthodontic archwire
Device name
Arch wires (nickel-titanium alloy )
Model / reference
-270-0430
Primary DI / UDI-DI
EFOR27004301
Basic UDI-DI
++EFOR020106DL
Unit of use DI
EFOR27004301001
FDA product code
DZC
EMDN code
Q010405 Orthodontic wires
GMDN term
Orthodontic archwire
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Germany
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 archwire

Similar devices in this category

Other devices filed under ORTHODONTIC WIRES.

Other devices from Forestadent Bernhard Förster GmbH

See all devices from Forestadent Bernhard Förster GmbH →

Properties

  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)