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Overjet Iris Intelligent Imaging System v1

by Overjet

Ref Overjet Iris Intelligent Imaging System

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

18 Sep 2030

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier Scarlet NB B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08600139278OJIIIS3T Basic UDI-DI 00860013927820UDI-DIDate2 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00860013927820 UDI-DI Date13 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-19.2.1.2 Active Supplemented

    Quality management system EU MDR

    Certifier
    Scarlet NB B.V. 3022
    Issued
    30 Jun 2026
    Expires
    18 Sep 2030
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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

Trade Name
Overjet Iris Intelligent Imaging System
Generic Name
Radiological PACS-dedicated management software
Model / Reference
Overjet Iris Intelligent Imaging System EUDAMED
v1 GUDID
Primary DI / UDI-DI
00860013927820
Basic UDI-DI
08600139278OJIIIS3T
510(k) Number
FDA Product Code
QIH
EMDN Code
Z12110192 Instruments for dental treatment units - medical device software
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Overjet Iris Intelligent Imaging System
GUDID
v1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Overjet

See all devices from Overjet →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No