Automated Projection Perimeter

The PTS 2000 automated projection perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects,…

Registry build 21.09.26

The PTS 2000 automated projection perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

7manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Chongqing (4), Jiangsu (2), Beijing (1).

Chinese manufacturers registered for FDA product code HPT
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
Chongqing Sunkingdom Medical Instrument Co., Ltd. Chongqing Chongqing Manufacturer 11
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

Record

Regulatory record for Automated Projection Perimeter
Listed by Optopol Technology SP Z O O
FDA product code HPT
Device type Perimeter, Automatic, Ac-Powered
Device class Class 1
Regulation 21 CFR 886.1605
Premarket notification Exempt
Record published 2018-03-09
Record revised 2023-07-12 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Automated Projection Perimeter
Catalogue number Size Status
PTS 2000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Perimeter Chongqing Sunkingdom Medical Instrument Co., Ltd. 7
Perimeter, Automatic, Ac-Powered Chongqing Kanghuaruiming S&T Co., Ltd.. 7
Automated Perimeter Optopol Technology SP Z O O 5
Virtual Field Virtual Field, Inc 4
Humphrey Field Analyzer 3 (HFA3) Carl Zeiss Meditec Inc 4
Carrot Virtual Field, Inc 3
Eli Ezer U.S. Ophthalmic, L.L.C. 2
SYL Chongqing SS Medical Equipments Co., Ltd. 2
VisionOne PeriVision SA 2
RetinaLogik Retinalogik Inc. 2
Maia Centervue 2
Medmont Automated Perimeter DAC Medmont International PTY Ltd 1

Showing 12 of 34. All products under Perimeter, Automatic, Ac-Powered

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