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aiOS

by Aidoc Medical Ltd.

Ref aiOS

aiOS is a Class I device made by Aidoc Medical Ltd, registered in EUDAMED on 6 May 2025 (Basic UDI-DI 729001805219AD) and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 07290018052198), 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 Number729001805219AD Basic UDI-DI Date6 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290018052198 UDI-DI Date14 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 729001805219AD registered 6 May 2025 Active
  • FDA GUDID UDI-DI 07290018052198 listed 14 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290018052198
  2. Registered EUDAMED 729001805219AD

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  • Withdrawn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

Generic name
Radiology DICOM image processing application software
Model / reference
aiOS EUDAMED
3.x.y GUDID
4.x.y GUDID
Primary DI / UDI-DI
07290018052198, 07290018052402
Basic UDI-DI
729001805219AD
Direct marketing DI
07290018052198
07290018052402
FDA product code
LMD
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class I
Regulation number
892.2020
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
aiOS
GUDID
3.x.y
4.x.y

Manufacturer details

EUDAMED SRN
IL-MF-000030988
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Aidoc Medical Ltd

See all devices from Aidoc Medical Ltd →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)