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Ez3D-i 5.5

by Ewoosoft Co., Ltd.

Model Ez3D-i

Ez3D-i 5.5 is a device classified as Class IIa in the EU and Class II in the US made by Ewoosoft Co., Ltd., registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 88000197SW002JX) with CE/MDR certificate KR26/00000119 valid until 3 Sep 2031, cleared under FDA 510(k) K231757 on 14 Jul 2023 and listed in FDA GUDID since 26 Jul 2023 (UDI-DI 08800019700401), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

3 Sep 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

510(k) K231757

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000197SW002JX Basic UDI-DI 08800019700401UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019700401 UDI-DI Date26 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK231757 Date14 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000197SW002JX registered 29 Sep 2026 Active· +1 more in the status table
  • FDA 510(k) K231757 decided 14 Jul 2023 Active
  • FDA GUDID UDI-DI 08800019700401 listed 26 Jul 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR26/00000119 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    17 Sep 2026
    Expires
    3 Sep 2031
    Reason
    Change approved

Timeline

5 dated events

  1. Cleared FDA 510(k) K231757
  2. Listed FDA GUDID 08800019700401
  3. Certificate issued EUDAMED KR26/00000119
  4. Registered EUDAMED 88000197SW002JX
  5. Certificate expires EUDAMED KR26/00000119

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ez3D-i
Generic name
General-purpose dental x-ray system application software
Model / reference
Ez3D-i EUDAMED
5.5 GUDID
Primary DI / UDI-DI
08800019700401
Basic UDI-DI
88000197SW002JX
510(k) Number
FDA product code
LLZ
EMDN code
Z11079092 Various x-ray film imaging support instruments - medical device software
GMDN term
General-purpose dental x-ray system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Ez3D-i
GUDID
5.5
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.

Related devices

Category: General-purpose dental x-ray system application software

Similar devices in this category

Other devices filed under VARIOUS SUPPORTING INSTRUMENTS FOR X–RAY FILM IMAGING.

Other devices from Ewoosoft Co., Ltd.

  • EzOrtho

    Class IIa

  • Prora View

    Class IIa

  • EzDent-i v2.1

    Class II

  • EzDent-i v3.0

    Class II

See all devices from Ewoosoft Co., Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)