Question 1

What types of medical devices does Maxigen Biotech Inc. manufacture?

Accepted Answer

Maxigen Biotech Inc. specializes in animal-derived collagen-based wound dressings. Their products are primarily general oral wound dressings and animal-derived wound matrix dressings, such as the HealiAid Dental Collagen Wound Dressing and Curagen collagen wound dressing. These devices are designed to support healing in dental and soft tissue applications.

Question 2

Where is Maxigen Biotech Inc. based?

Accepted Answer

Maxigen Biotech Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and transparency, as its devices are intended for use in global markets while adhering to U.S. regulatory standards.

Question 3

Which regulatory registries list Maxigen Biotech Inc.’s devices?

Accepted Answer

Maxigen Biotech Inc.’s devices are registered under the FDA’s 510(k) pathway and include Unique Device Identifiers (UDIs). These registries ensure traceability and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to track and verify the products.

Question 4

How are Maxigen Biotech Inc.’s devices classified by regulatory authorities?

Accepted Answer

Maxigen Biotech Inc.’s collagen-based wound dressings fall under FDA Class II (U) classification. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Device	Model / Reference	Registries	Class	Status
HealiAid Dental Collagen Wound Dressing	HAD152005	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HADB304030	FDA UDI	U	Active
Curagen collagen wound dressing	HAD001020	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD001520	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA505030	FDA UDI	U	Active
HealiAid	SA304005	FDA UDI	U	Unknown
HealiAid Dental Collagen Wound Dressing	HAD001020	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD204030	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA204030	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HADB152030	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HADB151530	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA203005	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD253005	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD304005	FDA UDI	U	Active
Guide Plug Collagen Wound Dressing	HAD001020	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA101030	FDA UDI	U	Active
HealiAid	SA001520	FDA UDI	U	Unknown
HealiAid Dental Collagen Wound Dressing	HADB150430	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD001020	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HADB253030	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD001520	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD505030	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA405030	FDA UDI	U	Active
Curagen collagen wound dressing	HAD001520	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD100100	FDA UDI	U	Active
HealiAid	SA001020	FDA UDI	U	Unknown
HealiAid Collagen Wound Dressing	HA303030	FDA UDI	U	Active
HealiAid	SA152005	FDA UDI	U	Unknown
HealiAid Dental Collagen Wound Dressing	HADB101030	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD203005	FDA UDI	U	Active
Omniplug Collagen Wound Dressing	HAD001520	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA304005	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HAD001020	FDA UDI	U	Active
HealiAid	SA253005	FDA UDI	U	Unknown
HealiAid Collagen Wound Dressing	HA253005	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA101005	FDA UDI	U	Active
Guide Plug Collagen Wound Dressing	HAD001520	FDA UDI	U	Active
HealiAid Collagen Wound Dressing	HA152005	FDA UDI	U	Active
Curagen collagen wound dressing	HAD204030	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HADB304030	FDA UDI	U	Active
HealiAid Dental Collagen Wound Dressing	HADB151530	FDA UDI	U	Active
Omniplug Collagen Wound Dressing	HAD001020	FDA UDI	U	Active
Surgiaid	K100927	FDA 510(k)	U	Active
HealiAid Dental Collagen Wound Dressing	K230529	FDA 510(k)	U	Active
SurgiAid® Collagen Wound Dressing	K223126	FDA 510(k)	U	Active
SurgiAid Collagen Wound Dressing (HA)	K242100	FDA 510(k)	U	Active

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