Synthgene (Yixing) Health Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000054349
- Devices
- 53
- Registrations
- EUDAMED
What Synthgene (Yixing) Health Technology Co., Ltd. makes
Synthgene (Yixing) Health Technology Co., Ltd. manufactures a range of in vitro diagnostic (IVD) rapid test kits designed for point-of-care and home use. Their products include lateral flow assays for detecting drugs of abuse (THC, methamphetamine, amphetamines, and morphine), fecal occult blood (FOB), malaria antibodies, *Helicobacter pylori* antigen and antibodies, monkeypox virus antibodies, respiratory syncytial virus (RSV) antigen, human papillomavirus (HPV), and multi-drug combinations. The tests primarily use colloidal gold immunochromatography for visual result interpretation.
The company’s IVD products fall under the EU’s IVD General classification, requiring compliance with EU IVDR regulations. Their devices are registered in the euamed database, reflecting their listing under the European Union’s medical device regulatory framework. The manufacturer is based in China.
Catalogue
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- Regimes: CE IVDD Registry: EUDAMED
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Company details
- EUDAMED SRN
- CN-MF-000054349
- EUDAMED status
- Active
- EUDAMED registered name
- Synthgene (Yixing) Health Technology Co., Ltd.
- Registered address
- 2nd Floor,Area B and 4A02,4th Floor, Area A, Building 7,Yiyao Health Science and Technology Park, No.63 Science and Technology Avenue,Gaocheng Town, 214200, Yixing City, China
- [email protected]
- PRRC contact
- Jing Zheng