All FDSO products carry CE/FDA certifications and comply with international medical device standards. Below is our complete certification and testing documentation.
Compliant with EU Medical Device Regulation (MDR 2017/745). All products undergo CE conformity assessment.
Registered medical device manufacturer with the US FDA. Products comply with 21 CFR 820 quality system requirements.
Medical device quality management system certified, covering full lifecycle from design to delivery.
Comprehensive quality management system certification ensuring consistent product and service quality.
Composition analysis and physical property testing for stainless steel, titanium, and tungsten carbide — ensuring surgical-grade raw materials.
Autoclave tolerance testing data verifying instrument stability after 500+ cycles at 134°C.
Hardness, corrosion resistance, edge sharpness, and coating adhesion testing — comprehensive performance evaluation.
ISO 10993 compliant testing for cytotoxicity, sensitization, and irritation.
French/Japanese CrMo alloy steel — corrosion-resistant, heat-resistant, validated for 500+ autoclave cycles.
Only 60% the weight of stainless steel with excellent biocompatibility — ideal for long procedures and patients with metal allergies.
High-hardness tungsten carbide jaw and edge inserts lasting 5-10x longer than stainless steel, maintaining grip and sharpness.
Contact us to receive CE/FDA certificates, test reports, or material safety data sheets for any product.
Request DocumentsFrench/Japanese surgical-grade stainless steel (CrMo alloy) — precision forged, corrosion-resistant.
134°C autoclave sterilization, 500+ cycle tolerance. Maintains edge and structural integrity.
Suitable for routine restorative, endodontic, and periodontal procedures.
"Well-balanced, comfortable grip, no fatigue during long procedures." — Dr. Zhang, Shanghai
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