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Ortho Connect 3.0

by Biomedical Data Solutions Limited

Ref 6904414Model V3

Ortho Connect 3.0 is a device classified as Class A in the EU and Class II in the US made by Biomedical Data Solutions Limited, registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 5060496770066YT), listed under FDA premarket submission BK190434 and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 05060496770066), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK190434

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5060496770066YT Basic UDI-DI 05060496770066UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060496770066 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK190434 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5060496770066YT registered 15 Jun 2026 Active
  • FDA premarket submission BK190434 Active
  • FDA GUDID UDI-DI 05060496770066 listed 18 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060496770066
  2. Registered EUDAMED 5060496770066YT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ortho Connect
Generic name
Laboratory instrument/analyser application software IVD
Model / reference
V3 EUDAMED
6904414 EUDAMED
3.0 GUDID
Primary DI / UDI-DI
05060496770066
Basic UDI-DI
5060496770066YT
Direct marketing DI
05060496770066
FDA product code
KSZ
EMDN code
W02079082 Various general purpose IVD instruments - software accessories
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.9175
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
V3
6904414
GUDID
3.0
Device classEUDAMED
Class A
GUDID
Class II

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

Related devices

Category: Laboratory instrument/analyser application software IVD

Similar devices in this category

Other devices filed under VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Biomedical Data Solutions Limited

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Properties

  • Professional testing
  • Prescription use
Other properties (24, all answered No)