New Gene (Hangzhou) Bioengineering Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000013826
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- SUNGO Europe B.V.NL
What New Gene (Hangzhou) Bioengineering Co., Ltd. makes
New Gene (Hangzhou) Bioengineering Co., Ltd. manufactures COVID-19 antigen detection kits designed for nasal swab self-testing. These devices are intended for rapid point-of-care testing to identify active SARS-CoV-2 infections.
The company’s products are classified as in vitro diagnostic (IVD) devices for self-testing and are registered in the EU’s eudamed database. The manufacturer is based in China.
Catalogue
- Regimes: CE IVDD Registry: EUDAMED
- Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000013826
- EUDAMED status
- Active
- EUDAMED registered name
- New Gene (Hangzhou) Bioengineering Co., Ltd.
- EUDAMED abbreviated name
- New Gene Bioengineering
- Registered address
- 688, 688 Bin'an Road, Changhe Street, 310051, Hangzhou City, China
- Website
- www.new-gene.net/
- [email protected]
- PRRC contact
- Yang Zang
Frequently asked questions
How many devices does New Gene (Hangzhou) Bioengineering Co., Ltd. have in the registry?
The registry currently lists 2 devices for New Gene (Hangzhou) Bioengineering Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Gene (Hangzhou) Bioengineering Co., Ltd.'s devices?
Among its 2 most recently registered devices, New Gene (Hangzhou) Bioengineering Co., Ltd. has devices listed in EUDAMED (2 devices).
What risk classes do New Gene (Hangzhou) Bioengineering Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for New Gene (Hangzhou) Bioengineering Co., Ltd.'s devices are IVD devices for self-testing. Each device page shows its own class and authorisation.
What are the newest devices from New Gene (Hangzhou) Bioengineering Co., Ltd. in the registry?
The most recently registered devices listed for New Gene (Hangzhou) Bioengineering Co., Ltd. include COVID-19 Antigen Detection Kit-Nasal swab.