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Prora View

by Ewoosoft Co., Ltd.

Model EzDent-i

Prora View (EzDent-i) is a Class IIa device made by Ewoosoft Co., Ltd, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 88000197SW001JV) with CE/MDR certificate KR26/00000119 valid until 3 Sep 2031, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

3 Sep 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000197SW001JV Basic UDI-DI 08800019700548UDI-DIDate29 Sep 2026RegisteredStatusActive

Official records

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

3 dated events

  1. Certificate issued EUDAMED KR26/00000119
  2. Registered EUDAMED 88000197SW001JV
  3. Certificate expires EUDAMED KR26/00000119

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
EzDent-i
Model / reference
EzDent-i
Primary DI / UDI-DI
08800019700548
Basic UDI-DI
88000197SW001JV
EMDN code
Z11079092 Various x-ray film imaging support instruments - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000013229
Authorised representative
VATECH GLOBAL FRANCE SARL FR-AR-000009694

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

Properties

  • Measuring function
Other properties (13, all answered No)