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Neosoft, LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000007437 FEI 3005914761

Neosoft, LLC is a medical device manufacturer based in the United States, with 12 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I) as of 14 Nov 2026.

Devices
12
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 10
  • EUDAMED 2
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 11
  • EU Class I 1
Top EMDN categories
Identifiers
  • EUDAMED SRN US-MF-000007437
  • FDA FEI 3005914761
  • DUNS 079151785

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Neosoft, LLC makes

Neosoft, LLC makes MRI system application software, including products such as CAKE and suiteHEART. These are specific types of software applications used in conjunction with MRI systems.

The company's portfolio is regulated as Class II devices and is listed in the fda_510k and fda_udi registries. Neosoft, LLC is based in the US.

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

Catalogue12

Newest first, rows 1-12 of 12

Search and filter all 12 devices
Skip device list

  • suiteDXT Software Ref NS-02-050-0001

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • suiteHEART 4.0.4

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

  • suiteHEART 4.0.0

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

  • Cake 3.0.0

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

  • suiteHEART 5

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

  • suiteHEART 4.0.3

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

  • suiteHEART 3.0.1

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

  • suiteHEART 4.0.2

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

  • suiteHEART 4.0.1

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

  • suiteHEART 4.0.7

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

  • suiteHEART 4.0.6

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

  • Suiteheart Ref K130228

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

Rows 1-12 of 12

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000007437
FDA FEI number
3005914761
DUNS number
079151785
EUDAMED status
Active
EUDAMED registered name
NeoSoft LLC
EUDAMED abbreviated name
NeoSoft
Registered address
N27W23910 A Paul Road, 53072, Pewaukee, United States
PRRC contact
Tim Roloff(public in EUDAMED)

Frequently asked questions

How many devices does Neosoft, LLC have in the registry?

The registry currently lists 12 devices for Neosoft, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Neosoft, LLC's devices?

Among its 12 most recently registered devices, Neosoft, LLC has devices listed in EUDAMED (2 devices), FDA 510(k) (1 device) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Neosoft, LLC's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Neosoft, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Neosoft, LLC in the registry?

The most recently registered devices listed for Neosoft, LLC include suiteDXT Software, suiteHEART 4.0.4, suiteHEART 4.0.0 and CAKE 3.0.0.

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