Question 1

What types of medical devices does HRA Pharma America, Inc. manufacture?

Accepted Answer

HRA Pharma America, Inc. specializes in adhesive bandages and single-use scar-management dressings. Their primary focus is on blister care products, including various sizes and formulations, as well as corn treatments. These devices are designed for temporary skin protection and healing, often tailored for specific use cases like sports or general skin care.

Question 2

Where is HRA Pharma America, Inc. based?

Accepted Answer

The company is based in the United States. This location aligns with its regulatory compliance requirements for devices marketed in the U.S., including adherence to FDA guidelines.

Question 3

Which regulatory registries list HRA Pharma America, Inc.’s devices?

Accepted Answer

HRA Pharma America, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which include adhesive bandages and scar-management dressings like their blister care and corn treatment products.

Question 4

How are HRA Pharma America, Inc.’s devices classified under U.S. regulations?

Accepted Answer

All of HRA Pharma America, Inc.’s listed devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk medical devices, such as adhesive bandages and single-use scar-management dressings, which pose minimal risk to patients when used as intended.

Device	Model / Reference	Registries	Class	Status
Compeed Blister Mixed Sizes 10p (4+4+2) USA	00810000319985	FDA UDI	Class I	Active
Compeed Twin Pack Blister Medium 10p USA	00810000319961	FDA UDI	Class I	Active
Compeed Twin Pack Blister Extreme 5p USA	00810000310074	FDA UDI	Class I	Active
Compeed Blister Mix Pack 5p USA	00810000310036	FDA UDI	Class I	Active
Compeed Advanced Blister Care Medium 2p	00810000319978	FDA UDI	Class I	Active
Compeed Blister Medium 5p USA	00810000310012	FDA UDI	Class I	Active
Compeed Advanced Blister Care Medium Skin Tone x10	00810000318292	FDA UDI	Class I	Active
Compeed Advanced Blister Care Medium 10p	00810000319992	FDA UDI	Class I	Active
Compeed Advanced Blister Care Sports Mixed 9p (6+3)	00810000318025	FDA UDI	Class I	Active
Compeed Twin Pack Blister Sports Mixed 9ct	00810000310128	FDA UDI	Class I	Active
Compeed Twin Pack Blister Sml 6p USA	00810000310098	FDA UDI	Class I	Active
Compeed Corn Medium 10p USA	00810000310050	FDA UDI	Class I	Active
Compeed Twin Pack Blister Medium 2x5ct	00810000310067	FDA UDI	Class I	Active
Compeed Advanced Blister Care Medium 12p	00810000318018	FDA UDI	Class I	Active
Compeed Advanced Blister Care Medium 1p	00810000310166	FDA UDI	Class I	Active
Mederma Cold Sore 15ct	810000318162	FDA UDI	Class I	Active
Compeed Twin Pack Blister Sports Medium 8ct	00810000310111	FDA UDI	Class I	Active
Mederma Medical Grade Silicone Scar Sheet Large 4ct	00810000310265	FDA UDI	Class I	Active
Compeed Twin Pack Corn Med 10p USA	00810000310104	FDA UDI	Class I	Active
Compeed Advanced Blister Care High Heel 9p	00810000318032	FDA UDI	Class I	Active
Compeed Advanced Blister Care High Heel 8p (oyster)	00810000310180	FDA UDI	Class I	Active
Compeed Advanced Blister Care Mixed Size (6+4+2) 12p	00810000318001	FDA UDI	Class I	Active
Compeed Twin Pack Blister High Heel 9ct	00810000310135	FDA UDI	Class I	Active
Compeed Trio-pack Medium 2ct + Small 6ct + Sports Extreme 5ct	00810000310210	FDA UDI	Class I	Active
Compeed Blister Small 6p USA	00810000310043	FDA UDI	Class I	Active
Compeed Twin Pack Blister Mix Pack 2+2+1p USA	00810000310081	FDA UDI	Class I	Active
Compeed Twin Pack Blister Mix Pack 4+4+2p USA	00810000319954	FDA UDI	Class I	Active
Mederma Medical Grade Silicone Scar Sheet Small 4ct	00810000310258	FDA UDI	Class I	Active
Compeed Blister Sport Pack 5p USA	00810000310029	FDA UDI	Class I	Active
Compeed Twin Pack Med 2ct	00810000310203	FDA UDI	Class I	Active
Compeed Advanced Blister Care Sports Medium 8 p	00810000318049	FDA UDI	Class I	Active
Compeed Advanced Blister Care Mixed 6	00810000310371	FDA UDI	Class I	Active

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