Home›USA›Merge Healthcare Incorporated

Merge Healthcare Incorporated

USA · Hartland

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 18 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

10active device licences

Class II 10

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 8 510(k), 0 PMA, 2 excluded

Canada10 confirmed, 1 excluded

Manufacturer names merged into this page: Merge Healthcare Incorporated · MERGE HEALTHCARE INCORPORATED

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250301	Merge Universal Viewer (MUV)	2025-04-14
US	K233326	Merge Hemo, Model RCSV2	2024-06-21
US	K203104	IBM iConnect Access	2021-01-26
CA	66447	VERICIS CARDIAC ACQUISITION - ECHO	Class II
CA	75471	MERGE CARDIO	Class II
CA	76496	UNITY RIS/PACS SOFTWARE	Class II

Merge Healthcare Incorporated

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies