Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 139

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 139
---
 contribute 
 to a death or serious injury, if the malfunction were to recur;                                                                   |

| ● | correction, removal and                                                                                                              
 recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals   
 if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; |

| ● | the FDA’s recall                                                                                                                   
 authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing 
 laws and regulations; and                                                                                                          |

| ● | post-market surveillance                                                                                                             
 activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional 
 safety and effectiveness data for the device.                                                                                        |

Manufacturing processes for
medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls
for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation
and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file,
device history file, and complaint files. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA.
Failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations
and the recall or seizure of marketed products. The discovery of previously unknown problems with any marketed products, including unanticipated
adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of
its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal
of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory
compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements,
it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

| ● | warning letters, untitled                                         
 letters, fines, injunctions, consent decrees and civil penalties; |

| ● | recalls, withdrawals, or                             
 administrative detention or seizure of our products; |

| ● | operating restrictions                                 
 or partial suspension or total shutdown of production; |

| ● | refusing or delaying requests                           
 for PMA approvals of new products or modified products; |