Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 57

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 57
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 products, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with the essential requirements we
must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for
low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue a European Community, or EC, Declaration
of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directive,
a conformity assessment procedure requires the intervention of an organization accredited by a member state of the EEA to conduct conformity
assessments, or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit and
examine the technical file and the quality system for the manufacture, design and final inspection of our devices. The Notified Body issues
a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical
device and its manufacturer and their conformity with the essential requirements. This certificate entitles the manufacturer to affix
the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

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As a general rule, demonstration
of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation
of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must
demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and
any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made
about the performance and safety of the device are supported by suitable evidence. If we fail to remain in compliance with applicable
European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling
them within the EEA.

Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.

If we receive regulatory clearance
or approval of the GelrinC or other future products, we will remain subject to ongoing and pervasive regulatory requirements governing,
among other things, the manufacture, marketing, advertising, medical device reporting, sale, promotion, import, export, registration,
and listing of devices. For example, we