Chongqing BIO Newvision Medical Equipment Ltd.

Manufacturer and brand owner in Chongqing, China. 2 device types, 1 product catalogued, 1 clearance.

Registry build 21.09.26

Chongqing BIO Newvision Medical Equipment Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Camera, Ophthalmic, Ac-Powered, Camera, Ophthalmic, General-Use. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2020.

2device types registered with the FDA
1product
1510(k) clearance

Registration

FDA registration record for Chongqing BIO Newvision Medical Equipment Ltd.
Registered name CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD.
Status Registered
Registration expires 2026
Registration number 3016589969
FEI number 3016589969
DUNS 540754972
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Chongqing BIO Newvision Medical Equipment Ltd.
Chinese legal name 重慶貝奧新視野醫療設備有限公司
Source Hong Kong company register lookup

Location

Address of Chongqing BIO Newvision Medical Equipment Ltd.
City Chongqing
Province Chongqing
Address 2nd floor of building #5,27 Fengsheng Road,Jinfeng Town,High-Tech Industrial Development Zone
Postal code 401329
Country China

What It Makes

Device types Chongqing BIO Newvision Medical Equipment Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Camera, Ophthalmic, Ac-Powered Class 2 Fundus Camera RetiCam 3100, Fundus Camera Kestrel 3100m 2020 3
Camera, Ophthalmic, General-Use Class 2 Fundus Camera,Model:Kestrel 300, Fundus Camera,Model:RetiCam 3100 Plus 2023 14

Own-Brand Listings

Devices catalogued by Chongqing BIO Newvision Medical Equipment Ltd.
Product Code Catalogue numbers
Syseye HKI 1

Clearances

510(k) clearances naming Chongqing BIO Newvision Medical Equipment Ltd. or its listings
Clearance Decision date Product code Route Held by
K190954 2020-01-22 HKI Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Chongqing BIO Newvision Medical Equipment Ltd.
Founded 2011
Employees 300+
Factory area 20,000平方米
Main products Fundus Camera, OCT Machine, Ophthalmic Ultrasound, Tonometer, Visual Field Analyzer
Certifications ISO13485, CE, National High-Tech Enterprise
Export markets 80+ countries including Europe, America, Asia, Africa
OEM and ODM Offered

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer