Synthgene (Yixing) Health Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000054349
- Devices
- 53
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
HCG Rapid Test Kit Ref YS002
FOB Rapid Test Kit Ref CR009
H. Pylori Antigen Rapid Test Kit Ref CR007
DP013 Ref DP013
Monkeypox Virus Antibody Rapid Test Kit Ref CR015
HPV Rapid Test kit Ref FK006
Monkeypox Virus Antigen Rapid Test Kit Ref CR017
Syphilis (TP) Antibody Rapid Test Kit Ref CR003
Showing 1-50 of 53
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
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.
Frequently asked questions
How many devices does Synthgene (Yixing) Health Technology Co., Ltd. have in the registry?
The registry currently lists 53 devices for Synthgene (Yixing) Health Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synthgene (Yixing) Health Technology Co., Ltd.'s devices?
Among its 50 most recently registered devices, Synthgene (Yixing) Health Technology Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Synthgene (Yixing) Health Technology Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Synthgene (Yixing) Health Technology Co., Ltd.'s devices are IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Synthgene (Yixing) Health Technology Co., Ltd. in the registry?
The most recently registered devices listed for Synthgene (Yixing) Health Technology Co., Ltd. include COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method), SP 10 Rapid Test Kit (Colloidal gold method), MQL Rapid Test Kit (Colloidal gold method) and EDDP Rapid Test Kit (Colloidal gold method).