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Merge Universal Viewer

by Merge Healthcare Incorporated United States EUDAMEDGUDID

Ref 100-00001-01 Product code LLZEMDN Z110603

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00842000101093 Basic UDI-DIDate17 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00842000101093 UDI-DIDate21 Sep 2021ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Radiology picture archiving and communication system workstation
Model / Reference
100-00001-01 EUDAMED
9.2 GUDID
8.3 GUDID
Primary DI / UDI-DI
00842000101093, 00842000101024
Basic UDI-DI
B-00842000101093, 08420001PACSCL
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z110603 Picture archiving and communication systems
GMDN Term
Radiology picture archiving and communication system workstation
Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
-1192
Software
Market of Registration
Ireland
Northern Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
100-00001-01
GUDID
9.2
8.3
Device ClassEUDAMED
Class IIa
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001275
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Merge Healthcare Incorporated

See all devices from Merge Healthcare Incorporated →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (20)
  • 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
  • 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

Sources (4)

  • EUDAMED 376e6048-d097-4d56-b4de-b6d750700dd9 61 fields · synced 22 Oct 2026
  • FDA UDI 2e01e0fa-9c3b-4cb0-98bd-04dcb72d2d0b 34 fields · synced 30 May 2026
  • FDA UDI 34b30f2d-8a15-40ba-a517-5219d632c121 33 fields · synced 30 May 2026
  • EUDAMED 00842000101024|08420001PACSCL 61 fields · synced 24 Oct 2026