Suzhou GenDx Biotech Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000018830
- Devices
- 4
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- CMC Medical Devices & Drugs SLES
Catalogue
GENEYE® System Ref GCP-30
GENEYE® Mycoplasma Pneumoniae Assay Ref RP003
Company details
- EUDAMED SRN
- CN-MF-000018830
- EUDAMED status
- Active
- EUDAMED registered name
- Suzhou GenDx Biotech Co., Ltd.
- Registered address
- No.38 Beiguandu Road, 2F, Building 3, No.38 Beiguandu Road, Yuexi Street, Wuzhong District, 215128, Suzhou, Jiangsu, China
- [email protected]
- PRRC contact
- Harriet Huang
Frequently asked questions
How many devices does Suzhou GenDx Biotech Co., Ltd. have in the registry?
The registry currently lists 4 devices for Suzhou GenDx Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou GenDx Biotech Co., Ltd.'s devices?
Among its 4 most recently registered devices, Suzhou GenDx Biotech Co., Ltd. has devices listed in EUDAMED (4 devices).
What risk classes do Suzhou GenDx Biotech Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Suzhou GenDx Biotech 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 Suzhou GenDx Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou GenDx Biotech Co., Ltd. include GENEYE® System, GENEYE® Respiratory Syncytial Virus（RSV）ERA Assay, GENEYE® Influenza Virus （FluA/B）ERA Assay and GENEYE® Mycoplasma Pneumoniae Assay.