Registrations and certifications
| Single-use flexible bronchoscope | FDA and CE (2020); NMPA registration (2021) |
|---|---|
| Single-use flexible rhinolaryngoscope | FDA cleared; sold in the US by Olympus as E-SteriScope; NMPA registration (2022) |
| Single-use flexible ureteroscope | NMPA registration (2022) |
| Single-use flexible cystoscope | NMPA registration (2022); certificate No. 湘械注准 20222061967 |
| Quality management system | MDSAP certified in December 2021; compliant with regional safety and quality standards |
| Testing capability | In-house testing centre accredited by SGS as a CTF laboratory, January 2024 |
Corporate qualifications
- National High-tech Enterprise
- National Intellectual Property Advantage Enterprise
- Hunan Specialised and Sophisticated SME (“Little Giant”)
- Hunan New R&D Institution and Hunan Enterprise Technology Centre
- Hunan Engineering Technology Research Centre for Single-use Electronic Endoscopes, jointly built with Xiangya Hospital of Central South University
- Key product of Hunan’s biomedicine industry; “Three Products” benchmark enterprise of Hunan’s consumer goods industry
- China Innovative Medical Device Top 100
Notes
The categories and years above reflect public information published by the company and indicate the markets each product can serve; they do not replace the certificates themselves. For tenders, registration and customs clearance, request certificate numbers, validity, scope and letters of authorisation through the online inquiry form.
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