Data / Medical devices / China / Chongqing Bio Newvision Medical Equipment Ltd.
Chongqing Bio Newvision Medical Equipment Ltd.: FDA-registered device maker in Chongqing, China, 1 510(k) clearance
Chongqing Bio Newvision Medical Equipment Ltd. is registered with the FDA (registration 3016589969) in Chongqing, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016589969
- Address
- 2nd floor of building #5,27 Fengsheng Road,Jinfeng Town,High-Tech Industrial Development Zone, Chongqing, China, 401329
- Owner or operator
- Chongqing Bio NewVision Medical Equipment Ltd. (10062546)
- Roles
- Manufacturer
- First device listed
- February 11, 2020
- Registered through
- 2026
- Brand names listed
- Fundus Camera Kestrel 3100m, Fundus Camera RetiCam 3100, Fundus Camera,Model:Kestrel 300, Fundus Camera,Model:RetiCam 3100 Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Ophthalmic, General-Use | PJZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2020 | K190954 | Fundus Camera | HKI | Substantially Equivalent | Chongqing Bio Newvision Medical Equipment , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 22, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.