Leadgene Biomedical, Inc.
Active in EUDAMEDTaiwanfrom SRN EUDAMED SRN TW-MF-000037178
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Leadgene® Indoxyl Sulfate (IS) ELISA Kit Ref LGM-18002-01
Regimes: CE IVDR Registry: EUDAMEDLeadgene® Indoxyl Sulfate (IS) ELISA Kit Ref LGM-18002
Regimes: CE IVDR CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- TW-MF-000037178
- EUDAMED status
- Active
- EUDAMED registered name
- Leadgene Biomedical, Inc.
- EUDAMED abbreviated name
- Leadgene
- Registered address
- No.9, Ln. 147, Zhengbei 1st Rd., Yongkang Dist., 71042, Tainan City, Taiwan
- Website
- www.leadgenebio.com
- [email protected]
- PRRC contact
- Tzu-Ling Tseng
Frequently asked questions
How many devices does Leadgene Biomedical, Inc. have in the registry?
The registry currently lists 2 devices for Leadgene Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Leadgene Biomedical, Inc.'s devices?
Among its 2 most recently registered devices, Leadgene Biomedical, Inc. has devices listed in EUDAMED (2 devices).
What risk classes do Leadgene Biomedical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Leadgene Biomedical, Inc.'s devices are IVDR Class B and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Leadgene Biomedical, Inc. in the registry?
The most recently registered devices listed for Leadgene Biomedical, Inc. include Leadgene® Indoxyl Sulfate (IS) ELISA Kit.