Rayce Biotechnology (Beijing) Co., Ltd
China CN-MF-000048156 Last updated 23 May 2026
- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Dry Fluorescence Immunoassay Analyzer Ref FIC-S100
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What Rayce Biotechnology (Beijing) Co., Ltd makes
Rayce Biotechnology (Beijing) Co., Ltd manufactures a Dry Fluorescence Immunoassay Analyzer, a diagnostic device designed for in vitro testing of biological samples. This analyzer performs immunoassays using fluorescence detection to quantify specific analytes, such as hormones, infectious agents, or biomarkers, in clinical or research settings. The system is intended for automated processing of test samples with minimal user intervention, providing rapid and precise results.
The company’s Dry Fluorescence Immunoassay Analyzer falls under Class A devices per EU regulations and is registered in the euamed database. While the device is listed in the European Union’s medical device registry, its regulatory classification and compliance status are determined by the specific jurisdiction where it is marketed. The manufacturer is based in China.
Frequently asked questions
What types of medical devices does Rayce Biotechnology (Beijing) Co., Ltd manufacture?
Rayce Biotechnology (Beijing) Co., Ltd specializes in the Dry Fluorescence Immunoassay Analyzer, a diagnostic device used for in vitro testing. This analyzer detects and quantifies specific biological analytes, such as hormones, infectious agents, or biomarkers, in clinical or research settings. The technology relies on fluorescence detection to provide automated, precise results with minimal user input.
Where is Rayce Biotechnology (Beijing) Co., Ltd based?
The company is headquartered in China. While the specific location within China isn’t detailed, its primary operational base is in Beijing, where it develops and manufactures its medical devices.
In which regulatory registries are Rayce Biotechnology’s devices listed?
The company’s Dry Fluorescence Immunoassay Analyzer is registered in the euamed database, which is the European Union’s official medical device registry. This listing indicates the device’s presence in the EU market, though its regulatory classification and compliance depend on the jurisdiction where it is sold.
How are Rayce Biotechnology’s devices classified under EU regulations?
The Dry Fluorescence Immunoassay Analyzer falls under Class A classification in the EU. This classification is determined by factors like the device’s risk level and intended use. Class A devices are generally considered low-risk, but compliance and authorization requirements still apply based on the specific regulatory framework of the country where the device is marketed.
Information
- Country
- China
- Address
- Room 217, 101 Inner, 1st to 4th Floor, Building 2, No. 12, Changsheng Road, Science and Technology Park, Beijing, China
- Website
- qq.com
- [email protected]
- PRRC contact
- Hang Yin
- EUDAMED SRN
- CN-MF-000048156