Shenzhen Hailife Biotechnology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000042748
- Devices
- 6
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Medunion S.L.ES
What Shenzhen Hailife Biotechnology Co., Ltd. makes
Shenzhen Hailife Biotechnology Co., Ltd. manufactures point-of-care hematology analyzers, such as the Hailife POC Hematology Analyzer, alongside consumables like lysing solutions and hematology analysis kits designed for blood testing.
The company’s products are classified under Class A and IVD General device categories, with some devices registered in the EU’s eudamed database. The manufacturer is based in China.
Catalogue
- Regimes: CE IVDD Registry: EUDAMED
Lysing Solution Ref R100302EN
Regimes: CE IVDR Registry: EUDAMEDLysing Solution Ref R100303EN
Regimes: CE IVDR Registry: EUDAMEDHematology Analysis Kit Ref R100502EN
Regimes: CE IVDR Registry: EUDAMEDHematology Analysis Kit Ref R100504EN
Regimes: CE IVDR Registry: EUDAMED- Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000042748
- EUDAMED status
- Active
- EUDAMED registered name
- Shenzhen Hailife Biotechnology Co., Ltd.
- Registered address
- No.22, Jinxiu Road, 518000, Shenzhen, China
- [email protected]
- PRRC contact
- Pei Lin
Frequently asked questions
How many devices does Shenzhen Hailife Biotechnology Co., Ltd. have in the registry?
The registry currently lists 6 devices for Shenzhen Hailife Biotechnology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Hailife Biotechnology Co., Ltd.'s devices?
Among its 6 most recently registered devices, Shenzhen Hailife Biotechnology Co., Ltd. has devices listed in EUDAMED (6 devices).
What risk classes do Shenzhen Hailife Biotechnology Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Shenzhen Hailife Biotechnology Co., Ltd.'s devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Hailife Biotechnology Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Hailife Biotechnology Co., Ltd. include Hailife POC Hematology Analyzer, Lysing Solution, Hematology Analysis Kit and Hailife POC Hematology Analyer.