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Merge Healthcare Incorporated

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000001275 FEI 1000116130

Devices
10
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI
Authorised rep.
Emergo Europe B.V.NL

What Merge Healthcare Incorporated makes

Merge Healthcare Incorporated manufactures medical imaging software and diagnostic tools, including cardiac imaging systems (Merge Cardio), picture archiving and communication systems (Merge PACS), and universal viewer platforms (Merge Universal Viewer) for radiology workflows. Their portfolio also includes hemoglobin measurement devices (Merge Hemo and Model RCSV2) and connectivity solutions (IBM iConnect Access) for integrating imaging data across healthcare systems.

The company’s devices are regulated under FDA 510(k) clearance in the US and listed in the EU’s EUDAMED database, with most classified as Class II or Class IIa medical devices. Their products are designed for diagnostic and imaging applications in clinical settings.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10

Newest first, rows 1-10 of 10

  • Merge Cardio Ref K192276

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Merge Universal Viewer (MUV) Ref K250301

    Active Regimes: CE MDD 510(k) Registry: 510(k) Class:II

  • Merge Hemo Ref K152864

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • IBM iConnect Access Ref K203104

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • IBM iConnect Access Ref K182290

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Merge Hemo, Model RCSV2 Ref K233326 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Merge PACS Ref K173475

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Merge PACS Ref K192455 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Merge Universal Viewer Ref 100-00001-01

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Merge Universal Viewer Ref 100-00001-01

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

Company details

EUDAMED SRN
US-MF-000001275
FDA FEI number
1000116130
EUDAMED status
Active
EUDAMED registered name
Merge Healthcare Incorporated
Registered address
900, Walnut Ridge Drive, 53029, Hartland, United States
PRRC contact
Nadia Marchant(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 29 Apr 2029

EUDAMED certificates (1)

SGS Belgium NV 1639 1 certificate

  • US24/00000159 Active Amended

    Quality management system EU MDR

    Issued
    20 Mar 2025
    Expires
    29 Apr 2029
    Reason
    Other

Frequently asked questions

How many devices does Merge Healthcare Incorporated have in the registry?

The registry currently lists 10 devices for Merge Healthcare Incorporated. Devices recorded under merged duplicate company entries are counted once.

Which registries list Merge Healthcare Incorporated's devices?

Among its 10 most recently registered devices, Merge Healthcare Incorporated has devices listed in EUDAMED (2 devices), FDA 510(k) (8 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Merge Healthcare Incorporated's devices fall under?

Among its 10 most recently registered devices, the classes recorded for Merge Healthcare Incorporated's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Merge Healthcare Incorporated?

EUDAMED lists 1 certificate for Merge Healthcare Incorporated (quality management system) under MDR. The most recent was issued on 20 Mar 2025.

What are the newest devices from Merge Healthcare Incorporated in the registry?

The most recently registered devices listed for Merge Healthcare Incorporated include Merge Cardio, Merge Universal Viewer (MUV), Merge Hemo and IBM iConnect Access.

Generated automatically from registry data and not verified by a human reviewer.