Geneseeq Medical Device and Diagnostic Inc.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000002104 FEI 3043140667
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Lotus NL B.V.NL
- Authorised rep.
- Riomavix Sociedad LimitadaES
What Geneseeq Medical Device and Diagnostic Inc. makes
Geneseeq Medical Device and Diagnostic Inc. produces in vitro diagnostic (IVD) tests, including a multi-cancer early detection kit and a SARS-CoV-2 nucleic acid detection kit using qRT-PCR technology.
These devices fall under the IVD General category and are listed in the EU’s eudamed registry. The company is based in China.
Catalogue
Geneseeq multi-cancer early detection kit Ref EU6054
Regimes: CE IVDD Registry: EUDAMED- Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000002104
- FDA FEI number
- 3043140667
- EU VAT number
- 320100000202005150024
- EUDAMED status
- Active
- EUDAMED registered name
- Geneseeq Medical Device and Diagnostic Inc.
- Registered address
- Building A-Floor 6, Building B Room B245-B261, No.128, Huakang Road, Pukou District, 210000, Nanjing,Jiangsu, China
- [email protected]
- PRRC contact
- xiuyan Zhang
Frequently asked questions
How many devices does Geneseeq Medical Device and Diagnostic Inc. have in the registry?
The registry currently lists 2 devices for Geneseeq Medical Device and Diagnostic Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Geneseeq Medical Device and Diagnostic Inc.'s devices?
Among its 2 most recently registered devices, Geneseeq Medical Device and Diagnostic Inc. has devices listed in EUDAMED (2 devices).
What risk classes do Geneseeq Medical Device and Diagnostic Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Geneseeq Medical Device and Diagnostic Inc.'s devices are IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Geneseeq Medical Device and Diagnostic Inc. in the registry?
The most recently registered devices listed for Geneseeq Medical Device and Diagnostic Inc. include Geneseeq multi-cancer early detection kit and SARS-CoV-2 Nucleic Acid Detection Kit（qRT-PCR）.