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Ensight

by Enlitic, Inc. EUDAMEDGUDID

Active European Union

Ref 10005

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00860002304557 UDI-DIDate22 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number008600023045EnsightX7 Basic UDI-DIDate13 May 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Radiology DICOM image processing application software
Model / Reference
10005 EUDAMED
2.0 GUDID
Primary DI / UDI-DI
00860002304557
Basic UDI-DI
008600023045EnsightX7
FDA Product Code
LMD
EMDN Code
V92 Medical device software - not included in other classes
GMDN Term
Radiology DICOM image processing application software
Device Class
Class I
Regulation Number
892.2020
Special Device Type
Software
Market of Registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10005
GUDID
2.0

Manufacturer details

EUDAMED SRN
US-MF-000022843
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties

  • Prescription Use
  • Premarket Exempt

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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No