Question 1

What types of medical devices does Tutogen Medical GmbH manufacture?

Accepted Answer

Tutogen Medical GmbH specializes in bioabsorbable and non-antimicrobial surgical mesh products derived from collagen. Their devices include extra-gynaecological surgical meshes made from bovine pericardium, such as Tutomesh™ and Tutopatch™, as well as animal-derived soft-tissue biomatrix implants for dental and maxillofacial applications, like Fortiva™ Porcine Dermis and Tutopatch™ ECM patches. These products are designed to support tissue regeneration in surgical procedures.

Question 2

Where is Tutogen Medical GmbH based?

Accepted Answer

Tutogen Medical GmbH is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, as it operates within the FDA’s jurisdiction.

Question 3

Which regulatory registries or databases list Tutogen Medical GmbH’s devices?

Accepted Answer

Tutogen Medical GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details, such as specifications and compliance status.

Question 4

How are Tutogen Medical GmbH’s devices classified under FDA regulations?

Accepted Answer

Tutogen Medical GmbH’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Question 5

What distinguishes Tutogen Medical GmbH’s devices from other surgical meshes or biomatrix implants?

Accepted Answer

Tutogen Medical GmbH’s devices are primarily differentiated by their animal-derived collagen sources, including bovine pericardium and porcine dermis, which are used for bioabsorbable or long-term soft-tissue support. Their products are designed for extra-gynaecological surgical mesh applications (e.g., hernia repair) and dental/maxillofacial reconstruction, with a focus on biocompatibility and tissue integration. The use of extracellular matrix (ECM) technology in some products also supports natural healing processes.

Device	Model / Reference	Registries	Class	Status
Tutomesh™ bovine pericardium10x16 cm	BP3016	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD3535	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 14x20 cm	BP1420	FDA UDI	Class II	Active
Tutopatch™ ECM 8 cm x 14 cm	BPE814	FDA UDI	Class II	Active
COPIOS® Pericardium Membrane	xz0134	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 12x16 cm	BP1216	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD0606	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 8x14 cm	BP0814	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD0808	FDA UDI	Class II	Active
Tutopatch™ ECM 7.5 cm x 10 cm	BPE710	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 8x16 cm	BP0816	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD3030	FDA UDI	Class II	Active
COPIOS® Pericardium Membrane	xz0123	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD2020	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium10x12.5 cm	BP1013	FDA UDI	Class II	Active
COPIOS® Pericardium Membrane	xz0112	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD0822	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD2035	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD1025	FDA UDI	Class II	Active
Tutomesh™ bovine pericardium 13x22 cm	BP3322	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD2025	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 12x12 cm	BP1212	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 8x18 cm	BP0818	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 6x8 cm	BP0608	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD1620	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 10x16 cm	BP1016	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD1016	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 6x18 cm	BP0618	FDA UDI	Class II	Active
Fortiva™ Porcine Dermis	PD1010	FDA UDI	Class II	Active
Tutopatch™ bovine pericardium 8x11 cm	BP0811	FDA UDI	Class II	Active
Tutopatch™ ECM 4 cm x 10 cm	BPE410	FDA UDI	Class II	Active

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