Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016159411

FEI Number

3016159411

Entity Name

E-Business International Inc.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 13, Tower C, Chuangwei Building, 008 Gaoxin South First Road, Hi-Tech Park, Nanshan District, Shenzhen Guangdong 518057, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

E-BI (Owner Number: 10061747)

Owner / Operator Contact Address

1400 112th Ave SE, Suite 100, Bellevue, WA 98004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203082

PMA Number

N/A

All Registered Proprietary Names

Vestibular First

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2026-03-12
GWN	Nystagmograph	Neurology	Class 2	882.1460	2021-01-04

Official Correspondent

Tanny Chiao

US Agent Details

Tanny Chiao Business: E-Business International Inc. Email: tanny.chiao@e-bi.com Phone: (503) 6442290

Related Public Records

Same Entity

E-BI

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27

Similar Registrations

Registration Number	Establishment Name	Location
3002956991	PAS SYSTEMS INTERNATIONAL INC	Durham, NC, US
3007343307	DA TECH CO LTD	Incheon, KR
3042276415	SHENZHEN MEIRUI SHANGPIN TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
3013585270	Consumer Safety Technology, LLC	Urbandale, IA, US
3013019743	SOBERLINK HEALTHCARE LLC	Huntington Beach, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016159411. Last updated year: 2026. Please use registration number 3016159411 when referencing this establishment in official correspondence.