Ustar Biotechnologies (Hangzhou) Ltd.
China CN-MF-000014615 Last updated 21 Oct 2026
- Devices
- 64
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Sample Reagent Ref U400094-10
MultNAT Carba-R Assay Ref U204016-20
PortNAT TB Assay Ref U201020-20
MultNAT GBS Assay Ref U203027-20
MultNAT MTC/RIF Assay Ref U201022-20
Sample Reagent Ref U400093-10
Sample Collection and Preservation Medium Ref U400090-20
Sample Reagent Ref U400094-100
Sample Reagent Ref U400081-10
Sample Reagent Ref U400094-20
Sample Reagent Ref U400078-20
Sample Preservation Solution Ref U400040-20
Sample Reagent Ref U400091-20
MultNAT EV Assay Ref U218005-20
MultNAT Tropical Fever Panel Ref U205015-10-C1
MultNAT MRSA/SA Assay Ref U204008-20
Sample Preservation Solution Ref U400010-100
MultNAT Tropical Fever Panel Ref U205015-10-C2
Sample Preservation Solution Ref U400037-100
Sample Preservation Solution Ref U400055-100
MultNAT Tropical Fever Panel Ref U205015-10-C4
Sample Preservation Solution Ref U400039-20
Sample Reagent Ref U400093-20
MultNAT MTC Assay Ref U201010-20
MultNAT SARS-CoV-2/Flu and RSV PCR Assay Ref U202043-20
MultNAT Respiratory Panel Ref U202039-5
Sample Preservation Solution Ref U400011-100
Sample Reagent Ref U400093-100
MultNAT C.difficile Assay Ref U204012-20
Sample Collection and Preservation Medium Ref U400079-20
MultNAT STI Panel Ref U203028-20
MultNAT Gastrointestinal Panel Ref U218006-10
MultNAT Molecular Diagnostic Testing System Ref U300014-4
MultNAT Molecular Diagnostic Testing System Ref U300014-2
EasyNAT HSV 1&2 Assay Ref U20304
Sample Reagent Ref U400059-20
EasyNAT UU Assay Ref U20303
Sample Reagent Ref U400077-20
EasyNAT MTC Assay Ref U20103
Sample Preservation Solution Ref U400023-100
Nucleic Acid Amplification and Detection Analyzer Ref U300005-8
EasyNAT GBS Assay Ref U20311
Sample Reagent Ref U400070-20
EasyNAT Rapid RSV Assay Ref U20208
EasyNAT CT/NG Assay Ref U203001-20
Sample Preservation Solution Ref U400014-100
Sample Preservation Solution Ref U400024-100
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EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 1 certificate
- V12 114190 0002 Amended
Quality management system EU IVDR
- Issued
- 1 Jul 2026
- Expires
- 10 Jul 2028
- Reason
- Mnf ar change
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Notified bodies
About
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.
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.
Frequently asked questions
What types of medical devices does Ustar Biotechnologies (Hangzhou) Ltd. manufacture?
Ustar Biotechnologies (Hangzhou) Ltd. specializes in nucleic acid amplification and detection systems, primarily for point-of-care (POCT) diagnostics. Their portfolio includes the EasyNAT series, which covers assays for infectious diseases like herpes simplex virus (HSV 1&2), group B streptococcus (GBS), cytomegalovirus (MTC), urinary tract infections (UU), and respiratory syncytial virus (RSV). Additionally, they produce sample reagents and preservation solutions to support pre-analytical sample handling, ensuring compatibility with their testing platforms.
Where is Ustar Biotechnologies (Hangzhou) Ltd. based, and how does that affect its regulatory landscape?
Ustar Biotechnologies (Hangzhou) Ltd. is headquartered in China, which means its devices must comply with both domestic Chinese regulations and international standards if marketed globally. While the company’s products are listed in the EU’s eudamed registry, this does not imply EU approval—it simply indicates registration under EU medical device regulations. Classification under IVD General, Class A, B, or C categories determines the regulatory pathway for each device in different markets.
Which regulatory registries list Ustar Biotechnologies’ devices, and why is this important?
Ustar Biotechnologies’ devices are listed in the eudamed registry, which is the EU’s central database for medical devices. This listing is important because it provides transparency to regulators, healthcare providers, and patients about the manufacturer and its products within the EU market. However, listing alone does not confirm regulatory clearance—it only indicates that the manufacturer has provided the necessary information to the EU authorities for oversight.
How are Ustar Biotechnologies’ devices classified, and what does this classification mean for their use?
Ustar Biotechnologies’ devices fall under IVD General, Class A, Class B, and Class C classifications. These classifications determine the level of risk associated with each device and dictate the regulatory requirements for market authorization. For example, Class C devices (higher risk) require more rigorous clinical evidence and scrutiny compared to Class A (lower risk) devices. The classification ensures that devices are evaluated proportionally to their potential impact on patient safety and diagnostic accuracy.
Information
- Country
- China
- Address
- 611, Dongguan Road, Binjiang District, Hangzhou, China
- Website
- en.bioustar.com/
- [email protected]
- Phone
- 86-4008707025
- PRRC contact
- Mingming Deng
- EUDAMED SRN
- CN-MF-000014615