Shanghai SUNGO Lab
Hefei SUNGO Lab
Professional medical device testing - covering the full product lifecycle
Comprehensive testing capabilities covering medical consumables, rehabilitation devices, active devices, and validation services.
One test meets global registration needs (FDA 510(K), EU CE, ChinaNMPA)
Testing of surgical packs, gowns, drapes, and isolation gowns - including barrier performance, water penetration resistance, breaking strength, and microbial barrier - to meet China registration and EU/US export requirements.
Testing for medical masks, gloves, dressings, and bandages - filtration efficiency, breathing resistance, tensile properties, bacterial filtration efficiency - covering all registration requirements.
Mechanical, electrical safety, and EMC testing for electric wheelchairs, mobility scooters, manual wheelchairs, walkers, and crutches - with full FDA 510(K) submission support.
Professional testing of syringes, infusion sets, catheters, dental instruments, ophthalmic instruments, surgical instruments, and other medical devices - with customized testing solutions.
Electrical safety testing including leakage current, dielectric strength, ground resistance, insulation resistance, touch current, and patient leakage current - ensuring electrical safety compliance.
EMC testing including conducted/radiated emissions, ESD, surge immunity, EFT, and voltage dips - meeting global EMC requirements.
Biological evaluation including cytotoxicity, skin irritation, sensitization, systemic toxicity, hemocompatibility, and implantation studies - providing scientific basis for product registration.
Shelf-life validation services including accelerated aging, real-time aging, stability studies, and expiration date verification - scientifically establishing product shelf life.
Cleaning, disinfection, EO sterilization, radiation sterilization, steam sterilization, and residue testing validation - ensuring effective sterilization processes.
Seal strength, peel strength, dye penetration, bubble leak, vacuum leak, and sterile barrier system validation - ensuring packaging integrity.
Drop, vibration, shock, compression, and temperature/humidity cycling tests - simulated transport validation ensuring safe shipping.
SUNGO Lab has testing capabilities covering major domestic and international medical device standards.
Professional credentials, extensive experience, efficient service - one test meets global registration needs
CNAS + CMA + IAS Triple accreditation, globally mutual-recognized reports, FDA 510(K) coaching capability - one test meets global registration needs.
Service 5000+ Client, 100+ FDA 510(K) Success Stories - 62.1% Market Share in the Wheelchair Sector, 30+ Countries Covered
Average testing cycle of 58 days. Dedicated project team for one-on-one service, rapid response, and real-time progress tracking.
ILAC-MRA International mutual recognition - reports accepted for China NMPA, US FDA, and EU CE registration -"One Test · Global Acceptance"