第二類医療機器シリーズ

The Class II Medical Device Series is the core of our contract manufacturing business, bringing together medical dressings, medical gels, hemostatic materials, hydra-lifting essences, freeze-dried fibers and facial masks under one certified umbrella. Every product in this series is manufactured under ISO 13485:2016 quality management and Class II device registration, with GMP cleanrooms, validated sterilization processes and complete technical documentation. We provide true end-to-end OEM/ODM service: formula development, prototype samples, pilot production, regulatory documentation support and scale-up to full production. With 110+ device registrations and export experience across 20+ countries, we help brands and distributors bring compliant medical products to market faster. Begin with a sample request and our team will guide you through specifications, MOQ and timelines.