Question 1

What types of medical devices does Forus Health Private Limited manufacture?

Accepted Answer

Forus Health Private Limited specializes in ophthalmic devices, specifically automated refractometers and ophthalmic fundus cameras. These tools are used in clinical settings to measure refractive errors (like nearsightedness or farsightedness) and capture detailed images of the retina, aiding in eye examinations and diagnostics. The company’s focus is on precision instruments for eye care.

Question 2

Where is Forus Health Private Limited based, and how does this affect its regulatory compliance?

Accepted Answer

Forus Health Private Limited is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including classification under the agency’s medical device hierarchy. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, demonstrating adherence to U.S. regulatory requirements for medical devices.

Question 3

How are the devices manufactured by Forus Health Private Limited classified under FDA regulations?

Accepted Answer

The devices produced by Forus Health Private Limited are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require less stringent controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.

Question 4

Which regulatory registries or databases list the devices made by Forus Health Private Limited?

Accepted Answer

The devices manufactured by Forus Health Private Limited are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and compliance with regulatory requirements. The UDI system is used to standardize device identification for better monitoring and recall management.

Question 5

What is the primary purpose of the 3nethra series and Ovitz Aberrometer devices produced by Forus Health?

Accepted Answer

The 3nethra series and the Ovitz Aberrometer are designed for clinical ophthalmic use. The 3nethra devices are automated refractometers and fundus cameras, primarily used to measure refractive errors and capture high-resolution retinal images during eye exams. The Ovitz Aberrometer, meanwhile, is specialized for assessing ocular aberrations, which are distortions in the eye’s optical system that can affect vision clarity. Both tools support precise diagnostics in eye care.

Device	Model / Reference	Registries	Class	Status
3nethra	Stand	FDA UDI	Class II	Active
3nethra	neo control box	FDA UDI	Class II	Active
3nethra	Classic camera	FDA UDI	Class II	Active
3nethra	classic stand	FDA UDI	Class II	Active
3nethra	classic camera	FDA UDI	Class II	Active
3nethra	classic HD stand	FDA UDI	Class II	Active
3nethra	aberro	FDA UDI	Class I	Active
Ovitz Aberrometer	P10	FDA UDI	Class I	Active
3nethra	classic HD camera	FDA UDI	Class II	Active
3nethra	neo probe	FDA UDI	Class II	Active
3nethra	neo P1000 control box	FDA UDI	Class II	Active
3nethra	classic 6.4	FDA UDI	Class II	Active
3nethra	neo probe	FDA UDI	Class II	Active
3nethra	neo control box	FDA UDI	Class II	Active
3nethra	neo P1000 probe	FDA UDI	Class II	Active

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