Nanjing Synthgene Medical Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000023810
- Devices
- 85
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Kingsmead Service B.V.NL
- Authorised rep.
- Lotus NL B.V.NL
- Authorised rep.
- MedPath GmbHDE
Catalogue
Search and filter all 85 devicesShowing 1-50 of 85
Company details
- EUDAMED SRN
- CN-MF-000023810
- EUDAMED status
- Active
- EUDAMED registered name
- Nanjing Synthgene Medical Technology Co., Ltd.
- EUDAMED abbreviated name
- Synthgene
- Registered address
- Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,, 210000, Nanjing, China
- Website
- www.syngenemed.com
- [email protected]
- Phone
- +86(025)83696681
- PRRC contact
- zheng jing
From the company website
NANJING SHINKYI PHARMACEUTICAL TECHNOLOGY CO. LTD. NANJING SHINKYI MEDICAL TECHNOLOGY CO. LTD. (Nanjing Synthgene Medical Technology Co., Ltd.) IS A HIGH-TECH COMPANY THAT FOCUSES ON THE DEVELOPMENT AND PRODUCTION OF BIOMEDICINE PRODUCTS BY OTC。
Frequently asked questions
How many devices does Nanjing Synthgene Medical Technology Co., Ltd. have in the registry?
The registry currently lists 85 devices for Nanjing Synthgene Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nanjing Synthgene Medical Technology Co., Ltd.'s devices?
Among its 50 most recently registered devices, Nanjing Synthgene Medical Technology Co., Ltd. has devices listed in EUDAMED (49 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nanjing Synthgene Medical Technology Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Nanjing Synthgene Medical Technology Co., Ltd.'s devices are Class II, IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Nanjing Synthgene Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Nanjing Synthgene Medical Technology Co., Ltd. include HC-10 Portable Colloidal Gold Immunoassay Analyzer, TRA Rapid Test Kit (Colloidal gold method), Dengue NS1 Rapid Test Kit (Colloidal gold method) and G17 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay).