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SafeID

by Vision RT Ltd. 2 variants

Ref SafeID 2.3

SafeID (SafeID 2.3) is a Class I device made by Vision RT Ltd., registered in EUDAMED on 24 May 2022 (Basic UDI-DI 5056190500702UZ) and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 05056190500801), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056190500801 UDI-DI Date14 Dec 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5056190500702UZ Basic UDI-DI 05056190500801UDI-DIDate24 May 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5056190500702UZ registered 24 May 2022 Active
  • FDA GUDID UDI-DI 05056190500801 listed 14 Dec 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED 5056190500702UZ
  2. Listed FDA GUDID 05056190500801

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  • Withdrawn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
Patient-administration information system application software
Model / reference
SafeID 2.3
Primary DI / UDI-DI
05056190500801
Basic UDI-DI
5056190500702UZ
Direct marketing DI
05056190500801
FDA product code
OUG
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Patient-administration information system application software
Device class
Class I
Regulation number
880.6310
Special device type
Software
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GB-MF-000010499
Authorised representative
Oticon A/S DK-AR-000006135

Related devices

Category: Device sterilization/disinfection container, reusable

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Vision RT Ltd.

See all devices from Vision RT Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)