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Bindex

by Bone Index Finland Oy

Ref 2Model BI-2

Bindex (2) is a bone absorptiometric ultrasound system (EU MDD Class IIa; FDA Class II; FDA product code MUA, Bone Sonometer) made by Bone Index Finland Oy, registered in EUDAMED on 18 Nov 2021 (Basic UDI-DI B-06430065790013) and listed in FDA GUDID since 16 Jan 2017 (UDI-DI 06430065790013), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06430065790013 Basic UDI-DI 06430065790013UDI-DIDate18 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06430065790013 UDI-DI Date16 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06430065790013 registered 18 Nov 2021 Active
  • FDA GUDID UDI-DI 06430065790013 listed 16 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06430065790013
  2. Registered EUDAMED B-06430065790013

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  • Withdrawn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

Generic name
Bone absorptiometric ultrasound system
Model / reference
BI-2, 2
Primary DI / UDI-DI
06430065790013
Basic UDI-DI
B-06430065790013
FDA product code
MUA
EMDN code
Z11040103 Portable ultrasound scanners
GMDN term
Bone absorptiometric ultrasound system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1180
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000006812

Similar devices in this category

Other devices filed under PORTABLE ULTRASOUND SCANNERS.

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)