Ningbo BESTest Bio-technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000041242
- Devices
- 8
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- SUNGO Europe B.V.NL
Catalogue
- Regimes: CE IVDR Registry: EUDAMED
- Regimes: CE IVDR CE IVDD Registry: EUDAMED
- Regimes: CE IVDD Registry: EUDAMED
Influenza A+B Antigen Rapid Test Kit (Nasal Swab Test) Ref IAB001-25
Regimes: CE IVDD Registry: EUDAMED- Regimes: CE IVDD Registry: EUDAMED
Influenza A+B Antigen Rapid Test Kit (Nasal Swab Test) Ref IAB001-01
Regimes: CE IVDD Registry: EUDAMEDInfluenza A+B Antigen Rapid Test Kit (Nasal Swab Test) Ref IAB001-05
Regimes: CE IVDD Registry: EUDAMED- Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000041242
- EUDAMED status
- Active
- EUDAMED registered name
- Ningbo BESTest Bio-technology Co.,Ltd.
- Registered address
- 7,8 Building, No. 108 Tongning Road, Jiangbei District, 315033, Ningbo，Zhejiang, China
- [email protected]
- Phone
- +86 18610595040
- PRRC contact
- Siyong Chen
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 19 Mar 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 809318 Active
Quality management system EU IVDR
- Issued
- 20 Mar 2026
- Expires
- 19 Mar 2031
Frequently asked questions
How many devices does Ningbo BESTest Bio-technology Co., Ltd. have in the registry?
The registry currently lists 8 devices for Ningbo BESTest Bio-technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ningbo BESTest Bio-technology Co., Ltd.'s devices?
Among its 8 most recently registered devices, Ningbo BESTest Bio-technology Co., Ltd. has devices listed in EUDAMED (8 devices).
What risk classes do Ningbo BESTest Bio-technology Co., Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Ningbo BESTest Bio-technology Co., Ltd.'s devices are IVDR Class B and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Ningbo BESTest Bio-technology Co., Ltd.?
EUDAMED lists 1 certificate for Ningbo BESTest Bio-technology Co., Ltd. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 20 Mar 2026.
What are the newest devices from Ningbo BESTest Bio-technology Co., Ltd. in the registry?
The most recently registered devices listed for Ningbo BESTest Bio-technology Co., Ltd. include Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma), Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold), Influenza A+B Antigen Rapid Test Kit (Nasal Swab Test) and SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab).