GUNZE LIMITED

Gunze Limited specializes in two primary categories of medical devices: extra-gynaecological surgical meshes made from synthetic polymers, including bioabsorbable variants, and animal-derived wound matrix dressings for chronic or complex wounds. Their product line includes meshed and non-meshed bilayer wound matrices (e.g., TheraGenesis) designed to aid tissue regeneration and wound healing, as well as a synthetic mesh dressing called NEOVEIL for surgical tissue integration.

Gunze Limited is headquartered in Japan, though its devices are registered and authorised globally. The company’s products are classified under EU Class II and III (with some as Class U for custom-made devices) and are listed in the EU’s eudamed database, the FDA’s 510(k) premarket notification program, and the FDA’s UDI system. Classification depends on risk level (e.g., surgical meshes are typically higher-risk than wound dressings), requiring compliance with regional regulations like the EU MDR or FDA QSR.

Gunze Limited’s devices appear in eudamed (EU’s medical device registry), FDA’s 510(k) (for premarket clearance of higher-risk devices like surgical meshes), and FDA’s UDI system (for traceability). Inclusion in these registries reflects their EU Class II/III or FDA Class II/III classification, mandating transparency for post-market surveillance, adverse event reporting, and compliance tracking. Animal-derived wound matrices (e.g., TheraGenesis) may also appear due to their tissue interaction risks.

Under EU regulations, Gunze’s devices are classified as Class II (moderate risk, e.g., some wound dressings) or Class III (high risk, e.g., surgical meshes requiring stringent clinical data). A few may fall under Class U (custom-made) if tailored to individual patients. In the FDA system, similar risk-based tiers apply: surgical meshes are typically Class II or III, while wound dressings like NEOVEIL are often Class II. Classification determines labeling, manufacturing controls, and post-market obligations.