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Forus Health Pvt.Ltd

IndiaFDA 510(k) applicant, unverified FDA

Devices
2
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Forus Health Pvt.Ltd makes

Forus Health manufactures the 3nethra neo, a retinal imaging device designed for ophthalmic diagnostics, and its high-definition variants (3nethra neo HD FA and 3nethra neo HD) for fluorescein angiography and detailed retinal visualization.

These devices are classified as Class II under FDA regulations and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • 3nethra neo Ref K183059

    Class II
    Active 510(k) 510(k) II
  • 3nethra neo HD FA; 3nethra neo HD Ref K243600

    Class II
    Active 510(k) 510(k) II

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Forus Health Pvt.ltd., Bengaluru Karnataka · IN FEI 3012162565

Frequently asked questions

How many devices does Forus Health Pvt.Ltd have in the registry?

The registry currently lists 2 devices for Forus Health Pvt.Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Forus Health Pvt.Ltd's devices?

Among its 2 most recently registered devices, Forus Health Pvt.Ltd has devices listed in FDA 510(k) (2 devices).

What risk classes do Forus Health Pvt.Ltd's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Forus Health Pvt.Ltd's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Forus Health Pvt.Ltd in the registry?

The most recently registered devices listed for Forus Health Pvt.Ltd include 3nethra neo and 3nethra neo HD FA; 3nethra neo HD.

Which FDA establishments are linked to Forus Health Pvt.Ltd?

1 FDA establishment is linked to Forus Health Pvt.Ltd in the registry; they are listed on the company page.

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