Visionflex

GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical grade quality images and video in Full HD 1080p resolution at the touch of a button.

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Shandong (1).

Chinese manufacturers registered for FDA product code FWB
Manufacturer City Province Registered as Device types
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Nanjing Jusha Display Technology Co., Ltd. Nanjing Jiangsu Manufacturer 7
Qingdao Hisense Medical Equipment Co., Ltd. Qingdao Shandong Manufacturer 5
LG Electronics Nanjing New Technology Co., Ltd. Nanjing Jiangsu Manufacturer 4
Arthrex Medical Device (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 3

Record

Regulatory record for Visionflex
Listed by Visionflex PTY Limited, Australia
FDA product code FWB
Device type Camera, Television, Surgical, Without Audio
Device class Class 1
Regulation 21 CFR 878.4160
Establishment Complaint-file establishment, Exporter
Record published 2020-08-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries manufacturing date, serial number
Packaging Flip box, aluminium case

Catalogue Numbers

Catalogue numbers for Visionflex
Catalogue number Size Status
VFGEISCAM1.04 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LG LG Electronics Inc. 25
Stryker Barco, Inc 5
VisionPro Stryker GmbH 1
Arthrex LG Electronics Inc. 1
32″ 4K OLED Surgical Display Stryker GmbH 1
MTS Medicapture, Inc. 1
Hisense Qingdao Hisense Medical Equipment Co., Ltd. 1

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.

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