Hunan Runmei Gene Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000017635
- Devices
- 3
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What Hunan Runmei Gene Technology Co., Ltd. makes
Hunan Runmei Gene Technology Co., Ltd. produces diagnostic test kits designed for the simultaneous detection of multiple respiratory pathogens, including SARS-CoV-2, influenza A and B, respiratory syncytial virus (RSV), and adenovirus using colloidal gold technology.
The company’s products fall under the In Vitro Diagnostic (IVD) General device class and are registered in the EU’s eudamed database. The manufacturer is based in China.
Catalogue
Automatic Biochemistry Analyzer Ref RM-R03-013-1.0
Regimes: CE IVDR Registry: EUDAMEDReagent Kit for Automatic Biochemistry Analyzer Ref RM-R03-014-1.0
Regimes: CE IVDD, withdrawn Registry: EUDAMED- Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000017635
- EUDAMED status
- Active
- EUDAMED registered name
- Hunan Runmei Gene Technology Co., Ltd.
- Registered address
- Room 401-1, Building 3, Shanhe Medical and Health Industrial Park, No. 1048, Zhongqing Road, Shaping Street, Kaifu District, 410005, Changsha, China
- [email protected]
- PRRC contact
- Wei Jiang
Frequently asked questions
How many devices does Hunan Runmei Gene Technology Co., Ltd. have in the registry?
The registry currently lists 3 devices for Hunan Runmei Gene Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hunan Runmei Gene Technology Co., Ltd.'s devices?
Among its 3 most recently registered devices, Hunan Runmei Gene Technology Co., Ltd. has devices listed in EUDAMED (3 devices).
What risk classes do Hunan Runmei Gene Technology Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hunan Runmei Gene Technology 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 Hunan Runmei Gene Technology Co., Ltd. in the registry?
The most recently registered devices listed for Hunan Runmei Gene Technology Co., Ltd. include Automatic Biochemistry Analyzer, Reagent Kit for Automatic Biochemistry Analyzer and SARS-CoV-2+FluA+B+RSV+Adeno Combo Test Kit(Colloidal Gold).