Ustar Biotechnologies (Hangzhou) Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000014615
- Devices
- 64
- Registrations
- EUDAMED
What Ustar Biotechnologies (Hangzhou) Ltd. makes
Ustar Biotechnologies (Hangzhou) Ltd. manufactures nucleic acid amplification and detection systems, including the EasyNAT series for point-of-care testing. These devices support assays for herpes simplex virus (HSV) types 1 and 2, group B streptococcus (GBS), cytomegalovirus (MTC), urinary tract infections (UU), and respiratory syncytial virus (RSV). The portfolio also includes sample reagents and preservation solutions designed for pre-analytical sample handling.
The company’s devices are classified under IVD General, Class A, Class B, and Class C categories and are listed in the EU’s eudamed registry. The manufacturer is based in China.
Catalogue
Search and filter all 64 devicesShowing 51-64 of 64
Company details
- EUDAMED SRN
- CN-MF-000014615
- EU VAT number
- 91330108770806481W
- EUDAMED status
- Active
- EUDAMED registered name
- Ustar Biotechnologies (Hangzhou) Ltd.
- Registered address
- 611, Dongguan Road, Binjiang District, 310053, Hangzhou, China
- Website
- en.bioustar.com/
- [email protected]
- Phone
- 86-4008707025
- PRRC contact
- Mingming Deng
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 10 Jul 2028
TÜV SÜD Product Service GmbH 0123 1 certificate
- V12 114190 0002 Active
Quality management system EU IVDR
- Issued
- 1 Jul 2026
- Expires
- 10 Jul 2028
- Reason
- Mnf ar change
From the company website
Ustar Biotechnologies (Hangzhou) Ltd. was established in 2005 and has been focused on the research, development, production, and sales of innovative point-of-care molecular diagnostic (POCT) technologies and products. The products and technologies have served over 3,000 medical institutions and are exported to more than 90 countries, actively contributing to the global control of major infectious diseases.