Shenzhen Lvshiyuan Biotechnology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000028164
- Devices
- 9
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Obelis S.A.BE
What Shenzhen Lvshiyuan Biotechnology Co., Ltd. makes
The company produces in vitro diagnostic (IVD) test kits for general chemistry, including a 12-test panel, as well as rapid diagnostic assays for prostate-specific antigen (PSA), ferritin, vitamin D (25-(OH)VD), and SARS-CoV-2 antigen detection.
These devices fall under the IVD General class and are registered in the EU’s eudamed database. The company is based in China.
Catalogue
TSH, FT3 and FT4 Rapid Test Kit Ref A26024008
Regimes: CE IVDD Registry: EUDAMEDSARS‐CoV‐2 Antigen Rapid Test Kit Ref HM048A
Regimes: CE IVDR Registry: EUDAMED- Regimes: CE IVDR Registry: EUDAMED
General Chemistry 12 Test Panel Ref A2650074
Regimes: CE IVDD Registry: EUDAMEDPSA and fPSA Rapid Test Kit Ref A26031007
Regimes: CE IVDD Registry: EUDAMEDHbA1c, Ferritin and 25-(OH)VD Rapid Test Kit Ref A26017009
Regimes: CE IVDD Registry: EUDAMEDSARS‐CoV‐2 Antigen Rapid Test Kit Ref 10 sets
Regimes: CE IVDD Registry: EUDAMEDSARS‐CoV‐2 Antigen Rapid Test Kit Ref 1 set
Regimes: CE IVDD Registry: EUDAMEDSARS‐CoV‐2 Antigen Rapid Test Kit Ref 25 sets
Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000028164
- EUDAMED status
- Active
- EUDAMED registered name
- Shenzhen Lvshiyuan Biotechnology Co., Ltd.
- EUDAMED abbreviated name
- Lvshiyuan
- Registered address
- 101, 201, 301, D Building, No. 2, Industrial Avenue, 518120, Shenzhen, China
- Website
- www.lsybt.com/
- [email protected]
- Phone
- +86-755-28438788
- PRRC contact
- Yuansheng CHEN
Frequently asked questions
How many devices does Shenzhen Lvshiyuan Biotechnology Co., Ltd. have in the registry?
The registry currently lists 9 devices for Shenzhen Lvshiyuan Biotechnology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Lvshiyuan Biotechnology Co., Ltd.'s devices?
Among its 9 most recently registered devices, Shenzhen Lvshiyuan Biotechnology Co., Ltd. has devices listed in EUDAMED (9 devices).
What risk classes do Shenzhen Lvshiyuan Biotechnology Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Shenzhen Lvshiyuan Biotechnology Co., Ltd.'s devices are IVDR Class B and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Lvshiyuan Biotechnology Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Lvshiyuan Biotechnology Co., Ltd. include TSH, FT3 and FT4 Rapid Test Kit, SARS‐CoV‐2 Antigen Rapid Test Kit, Flu A & Flu B & RSV & COVID-19 Ag Rapid Test Kit (Colloidal Gold) and General Chemistry 12 Test Panel.