Data / Medical devices / China / E-Business International Inc.
E-Business International Inc.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
E-Business International Inc. is registered with the FDA (registration 3016159411) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 12, 2020. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3016159411
- Address
- Floor 13, Tower C, Chuangwei Building 008 Gaoxin South First Road, Hi-Tech Park, Nanshan District, Shenzhen Guangdong, China, 518057
- Owner or operator
- E-BI (10061747)
- Roles
- Exporter to the US
- First device listed
- January 4, 2021
- Registered through
- 2027
- Brand names listed
- Vestibular First
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Exporter to the US | accessdata.fda.gov |
| Nystagmograph | GWN | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| November 12, 2020 | K203082 | Insight Infrared Video Goggles | GWN | Substantially Equivalent | Vestibular First | accessdata.fda.gov |
Compare with other makers
Updated November 12, 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.