Question 1

What types of medical devices does Bridon, Corp. manufacture?

Accepted Answer

Bridon, Corp. specializes in skin-closure adhesive strips. These devices are designed for wound or incision management, including post-surgical and minor procedure applications. They provide secure closure without the need for sutures or staples, making them suitable for dermatological and surgical settings.

Question 2

Where is Bridon, Corp. based?

Accepted Answer

Bridon, Corp. is based in the United States. The company’s headquarters and operations are located within the country.

Question 3

Which regulatory registries list Bridon, Corp.’s devices?

Accepted Answer

Bridon, Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S. by assigning a standardized identifier.

Question 4

How are Bridon, Corp.’s devices classified in the U.S.?

Accepted Answer

Bridon, Corp.’s skin-closure adhesive strips fall under Class III device classification in the U.S. This classification is typically assigned to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. The classification reflects the regulatory scrutiny required for these types of products.

Device	Model / Reference	Registries	Class	Status
BContak	B1332	FDA UDI	Class III	Active
BContak	B1693	FDA UDI	Class III	Active
BContak	B1332	FDA UDI	Class III	Active
BContak	B1693	FDA UDI	Class III	Active

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