HplanetBio (Shijiazhuang) Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000024035
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Lotus NL B.V.NL
What HplanetBio (Shijiazhuang) Co., Ltd makes
HplanetBio (Shijiazhuang) Co., Ltd manufactures real-time fluorescence-based quantitative PCR (qPCR) instruments, including models with 4-channel and 8-channel configurations. These devices are designed for nucleic acid amplification and detection in molecular biology applications, enabling high-throughput genetic analysis and pathogen testing.
The company’s qPCR instruments are classified as Class A medical devices under EU regulations and are listed in the EUDAQD (eudamed) registry. The devices are intended for use in research, clinical diagnostics, and molecular biology workflows, adhering to EU regulatory standards for low-risk in vitro diagnostic (IVD) devices.
Catalogue
- Regimes: CE IVDR Registry: EUDAMED
- Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000024035
- EU VAT number
- 91130123MA0DNW60XB
- EUDAMED status
- Active
- EUDAMED registered name
- HplanetBio (Shijiazhuang) Co.,Ltd
- Registered address
- No.501-24, the 5th floor, Building 5, Zone C, Fangyi Science Park, No.365, Huai 'an East Road, High-tech Zone, Shijiazhuang, Hebei, P. R. China., 050000, Shijiazhuang, China
- [email protected]
- Phone
- +86-311-85832890
- PRRC contact
- XIFU LIU
Frequently asked questions
How many devices does HplanetBio (Shijiazhuang) Co., Ltd have in the registry?
The registry currently lists 2 devices for HplanetBio (Shijiazhuang) Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list HplanetBio (Shijiazhuang) Co., Ltd's devices?
Among its 2 most recently registered devices, HplanetBio (Shijiazhuang) Co., Ltd has devices listed in EUDAMED (2 devices).
What risk classes do HplanetBio (Shijiazhuang) Co., Ltd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for HplanetBio (Shijiazhuang) Co., Ltd's devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from HplanetBio (Shijiazhuang) Co., Ltd in the registry?
The most recently registered devices listed for HplanetBio (Shijiazhuang) Co., Ltd include Real-time Fluorescence-based 4-Channel qPCR Instrument and Real-time Fluorescence-based 8-Channel qPCR Instrument.