CHARMANT INC.

Charmant Inc. specializes in reusable surgical instruments, focusing primarily on ophthalmic and general surgical applications. Their product range includes body aspiration needles, ophthalmic surgical probes, soft-tissue manipulation forceps (such as tweezers-like tools), eyelid speculums, intraocular scissors, vascular scissors, surgical instrument assist arm components, and specialized handling forceps. These devices are designed for precision in surgical environments, ensuring reliability and ease of use during procedures.

Charmant Inc. is headquartered in Japan. Their devices are listed in key regulatory databases, including eudamed (the EU’s medical device registry) and the FDA’s Unique Device Identifier (UDI) system, indicating compliance with both European and U.S. regulatory requirements for reusable surgical instruments. This reflects their adherence to international standards for medical device manufacturing and distribution.

Charmant Inc.’s devices fall under Class I classification in regulatory categorizations. This classification is typically assigned to low-risk medical devices, such as many reusable surgical instruments, where the risk of harm to patients is minimal. Class I devices often require less stringent regulatory oversight compared to higher-risk categories but still must meet safety, performance, and manufacturing standards.

Yes, Charmant Inc.’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s UDI system. This visibility in public registries ensures transparency for healthcare providers, regulators, and patients by providing verified information about the devices’ identities, classifications, and regulatory status. Listing in these databases also facilitates traceability and compliance verification during procurement or post-market surveillance.

Charmant Inc. emphasizes precision-engineered reusable instruments tailored for ophthalmic and general surgery, including specialized tools like ophthalmic soft-tissue forceps, intraocular scissors, and assist arm components. Their focus on reusable designs aligns with sustainability goals in healthcare while maintaining high standards for sterility and durability. The company’s inclusion in eudamed and FDA UDI further underscores their commitment to regulatory compliance, ensuring their devices meet global safety and performance benchmarks.