Question 1

What types of medical devices does Kerecis hf. manufacture?

Accepted Answer

Kerecis hf. specializes in bioabsorbable surgical meshes for extra-gynaecological applications, including collagen-based materials intended for tissue integration. Additionally, the company produces animal-derived wound matrix dressings for skin repair and protection, as well as wound care solutions containing omega-3 fatty acids. Surgical closure products, such as absorbable sutures and silicone-based wound sealants, are also part of its portfolio, alongside devices designed to guide tissue grafts in reconstructive surgeries.

Question 2

Where is Kerecis hf. based, and what regulatory framework does it follow?

Accepted Answer

Kerecis hf. is based in the United States. Its devices are developed and manufactured in compliance with applicable US regulatory requirements for medical devices, including those set by the FDA. The company’s products are classified under FDA’s Class II and Class U categories, which reflect their intended use and risk profiles.

Question 3

Which regulatory registries or databases list Kerecis hf.’s devices?

Accepted Answer

Kerecis hf.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the US market, helping healthcare providers and regulators identify and track specific products.

Question 4

How are Kerecis hf.’s devices classified by the FDA?

Accepted Answer

Kerecis hf.’s devices fall under FDA’s Class II and Class U classifications. Class II devices generally require special controls to ensure their safety and effectiveness, while Class U (custom devices) are typically one-of-a-kind or low-volume products tailored to individual patients. The classification depends on factors like risk level, intended use, and the potential impact on patient safety.

Question 5

What distinguishes Kerecis hf.’s wound care and surgical products from others in the market?

Accepted Answer

Kerecis hf.’s products are distinguished by their focus on bioabsorbable and collagen-based materials, which are designed to integrate with tissue over time. For wound care, the company incorporates animal-derived matrices and omega-3 fatty acids, which may support skin repair and protection. Surgical products like absorbable sutures and collagen meshes are tailored for specific applications, such as extra-gynaecological repairs or reconstructive procedures, ensuring compatibility with the body’s natural healing processes.

Device	Model / Reference	Registries	Class	Status
Kerecis® SurgiBind™	3x7 cm	FDA UDI	Class II	Active
Kerecis® SurgiClose®	6x8 cm Meshed 2:1	FDA UDI	U	Active
Kerecis® SurgiClose®	4x6 cm Meshed 2:1	FDA UDI	U	Active
Kerecis® Omega3 Wound	7x20 Solid Wound	FDA UDI	U	Unknown
Kerecis® MariGen™	Micro 38 sq cm	FDA UDI	U	Active
Kerecis® Shield™ Spiral	Diameter: 30mm	FDA UDI	U	Active
Kerecis® MariGen™	16 mm Circular	FDA UDI	U	Active
Kerecis® GraftGuide®	7x20 cm	FDA UDI	U	Active
Kerecis® SurgiClose® Silicone	6 x 14 cm fish skin	FDA UDI	U	Active
Kerecis® GraftGuide™ Mano	Size L, 196 sq cm Dorsum Left / Palmar Right Meshed 2:1	FDA UDI	U	Active
Kerecis® GraftGuide™ Mano	Size M, 147 sq cm Dorsum Left / Palmar Right Meshed 2:1	FDA UDI	U	Active
Kerecis® GraftGuide®	300 sq cm Meshed	FDA UDI	U	Active
Kerecis® Omega3 BURN	7x10 Meshed Burn	FDA UDI	U	Active
Kerecis® SurgiClose®	7x10 cm	FDA UDI	U	Active
Kerecis® SurgiClose®	7x10 cm Meshed 2:1	FDA UDI	U	Active
Kerecis® MariGen™	Expanse 7x8 cm	FDA UDI	U	Active
Kerecis® Omega3 BURN	10x25 Meshed Burn	FDA UDI	U	Active
Kerecis® MariGen™	Micro 8 sq cm	FDA UDI	U	Active
Kerecis® SurgiClose® Silicone	10 x 10 cm fish skin	FDA UDI	U	Active
Kerecis® Omega3 Wound	7x10 Meshed Wound	FDA UDI	U	Unknown
Kerecis® SurgiClose® Silicone	10 x 18 cm fish skin	FDA UDI	U	Active
Kerecis® Omega3 Wound	3x7 Fragmented Wound	FDA UDI	U	Unknown
Kerecis® GraftGuide®	300 sq cm Meshed 3:1	FDA UDI	U	Active
Kerecis® SurgiBind™	4x7 cm Fenestrated	FDA UDI	Class II	Active
Kerecis® SurgiBind™	3x20 cm	FDA UDI	Class II	Active
Kerecis® MariGen™	7x20 cm	FDA UDI	U	Unknown
Kerecis® GraftGuide™ Mano	Size M, 147 sq cm Dorsum Right / Palmar Left Meshed 2:1	FDA UDI	U	Active
Kerecis® MariGen™	Expanse 2x2 cm	FDA UDI	U	Active
Kerecis® SurgiBind™	300 sq cm	FDA UDI	Class II	Active
Kerecis® MariGen™	7x10 cm	FDA UDI	U	Active
Kerecis® GraftGuide®	250 sq cm	FDA UDI	U	Active
Kerecis® SurgiBind™	7x20 cm Fenestrated	FDA UDI	Class II	Active
Kerecis® Omega3 Wound	7x7 Particularized Wound	FDA UDI	U	Unknown
Kerecis® SurgiBind™	3x20 cm Fenestrated	FDA UDI	Class II	Active
Kerecis® MariGen™	Micro 19 sq cm	FDA UDI	U	Active
Kerecis® MariGen™	1.75x1.75 cm	FDA UDI	U	Active
Kerecis® SurgiBind™	3x12 cm Fenestrated	FDA UDI	Class II	Active
Kerecis® SurgiClose®	Micro 19 sq cm	FDA UDI	U	Unknown
Kerecis® Omega3 BURN	300cm2 Meshed Burn	FDA UDI	U	Active
Kerecis® MariGen™	Micro 4 sq cm	FDA UDI	U	Active
Kerecis® SurgiBind™	7x20 cm	FDA UDI	Class II	Active
Kerecis® SurgiBind™	3x12 cm	FDA UDI	Class II	Active
Kerecis® GraftGuide™ Mano	Size L, 196 sq cm Dorsum Right / Palmar Left Meshed 2:1	FDA UDI	U	Active
Kerecis® GraftGuide®	7x7 cm Meshed	FDA UDI	U	Active
Kerecis® MariGen™	3x7 cm	FDA UDI	U	Active
Kerecis® SurgiClose®	7x20 cm	FDA UDI	U	Active
Kerecis® Wound	12 mm Solid Circular Wound	FDA UDI	U	Unknown
Kerecis® SurgiBind™	300 sq cm Fenestrated	FDA UDI	Class II	Active
Kerecis® SurgiClose®	Micro 95 sq cm	FDA UDI	U	Active
Kerecis® GraftGuide®	7x20 cm Meshed	FDA UDI	U	Active

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