Fundus Camera

This equipment adopts advanced opto-mechanical and electrical integration technology, and integrates fundus digital image acquisition and image processing system. It can display color…

Registry build 21.09.26

This equipment adopts advanced opto-mechanical and electrical integration technology, and integrates fundus digital image acquisition and image processing system. It can display color fundus images continuously, real-time and high-quality.The fundus digital image acquisition and image processing system processes the static images of the fundus color images with full digital processing, completes real-time recording and storage, and can be used for image processing, inspection reports, graphic editing, and data retrieval management for medical record generation at any time. The size of the lesion can be measured and calculated, the image can be scaled, moved, and pasted, and the color of the image can be adjusted. The image data of the case can be exported to the U disk and attached to the patient’s case, which can assist scientific research and teaching

14manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Chongqing (5), Jiangsu (3), Zhejiang (2).

Chinese manufacturers registered for FDA product code PJZ
Manufacturer City Province Registered as Device types
Beijing Hongdee Corporation Beijing Beijing Private-label distributor 43
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Shanghai Link Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 21
Shanghai Mediworks Precision Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 13
Chongqing Sunkingdom Medical Instrument Co., Ltd. Chongqing Chongqing Manufacturer 11
Ningbo Ming Sing Optical R&D Co., Ltd. Ningbo Zhejiang Repacker / relabeller 9
Shenzhen Create Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Visuscience Meditech Co., Ltd. Wuxi Jiangsu Specification developer 9
Main Meditech Co., Ltd. Chongqing Chongqing Contract manufacturer 5
Chongqing Kanghua Ruiming S&T Co., Ltd. Chongqing Chongqing Contract manufacturer 3
Chongqing SS Medical Equipments Co., Ltd. Chongqing Chongqing Manufacturer 3
Chongqing BIO Newvision Medical Equipment Ltd. Chongqing Chongqing Manufacturer 2

Showing 12 of 14. All 14 manufacturers in China registered for Camera, Ophthalmic, General-Use

Record

Regulatory record for Fundus Camera
Listed by Chongqing Sunkingdom Medical Instrument Co., Ltd., China
FDA product code PJZ
Device type Camera, Ophthalmic, General-Use
Device class Class 2
Regulation 21 CFR 886.1120
Establishment Manufacturer
Premarket notification Exempt
Record published 2020-07-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number

Catalogue Numbers

Catalogue numbers for Fundus Camera
Catalogue number Size Status
SK-650A In distribution
SK-680A In distribution
SK-680C In distribution
SK-650B In distribution
SK-680B In distribution
SK-660A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 12
3nethra Forus Health Pvt.ltd., 12
Welch Allyn Medimaging Integrated Solution Inc. 6
D-EYE D-EYE SRL 4
Microclear Suzhou Microclear Medical Instruments Co., Ltd. 4
Mediworks Shanghai Mediworks Precision Instruments Co., Ltd. 3
EyeCaster Innovations Lightx Inc 3
Paxos Scope Digisight Technologies, Inc. 3
Remidio Remidio Innovative Solutions Inc 3
Volk Viva Volk Optical Inc. 2
Volk VistaView Volk Optical Inc. 2
PanoCam™ PRO Visunex Medical Systems Inc. 2

Showing 12 of 48. All products under Camera, Ophthalmic, General-Use

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