Refractor, Manual, Non-Powered, Including Phoropter

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Zhejiang, and 5 other provinces: 15 hold an FDA registration. 4 are contract manufacturers.

Beijing Hongdee Corporation Beijing
Chongqing Yeasn Science-Technology Co., Ltd. Chongqing, contract manufacturer
Danyang NEW Hope Medical Equipment Co., Ltd. Jiangsu
Gino Optical (Shanghai) Co., Ltd. Shanghai
Langfang FAR East Prosperous Optical Instrument Co., Ltd. Hebei, contract manufacturer
Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
Ningbo FLO Optical Technology Development Co., Ltd. Zhejiang
Ningbo Ming Sing Optical R&D Co., Ltd. Zhejiang
Shanghai Canton Optics Equipment Co., Ltd. Shanghai
Shanghai Huvitz Co., Ltd. Shanghai
Shanghai Link Instruments Co., Ltd. Jiangsu
Shenzhen Certainn Technology Co., Ltd. Guangdong
Taizhou City K&W International Trade Co., Ltd. Jiangsu
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Shaanxi, contract manufacturer
Wuxi Zontai Int'l Corporation Ltd. Jiangsu, contract manufacturer

What Is FDA Product Code HKN?

Refractor, Manual, Non-Powered, Including Phoropter is FDA product code HKN, Class 1, 21 CFR 886.1770.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Employee error (2), Process control (2) and Component design/selection (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Refractor, Manual, Non-Powered, Including Phoropter

Digital Refractor HDR-7000

Catalogue number HDR-7000, listed by Huvitz Co., Ltd., South Korea, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Tabletop Refraction System

The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box. • With the high precision LCD, visual acuity of 5 m…

Refractor, Manual, Non-Powered, Including Phoropter

1DIAL Controller KB-50S

Catalogue number KB-50S, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Infrared Communication Unit

Catalogue number INFRARED COMMUNICATION UNIT, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Digital Refractor HDR-9000

Catalogue number HDR-9000, listed by Huvitz Co., Ltd., South Korea, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Gilras

Gilras GR-1500 Manual Refractor

Refractor, Manual, Non-Powered, Including Phoropter

SightPilot NAVi Controller SNi-1 for Compu Vision CV-5000

Catalogue number SNi-1, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Digital Refractor

To check the refractive state of human eye.

Refractor, Manual, Non-Powered, Including Phoropter

SightChek Digital Phoropter

Catalogue number 16290, listed by Reichert Inc., United States, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Digital Refractor HDR-7100P

The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities. Also the Digital…

Refractor, Manual, Non-Powered, Including Phoropter

Fully Assisted Refraction System

In the conventional refraction, the patient answers the operator’s questions. According to their answers, the operator performs subjective refraction such as refining refractive errors…

Refractor, Manual, Non-Powered, Including Phoropter

Illuminix

Refractor instrument for trial lenses for subjective eye refraction examiation

Refractor, Manual, Non-Powered, Including Phoropter

Vision-S 700

Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular

Refractor, Manual, Non-Powered, Including Phoropter

Rexxam

This device is intended to evaluate refractive error and visual function from a subjective perspective.

Refractor, Manual, Non-Powered, Including Phoropter

Measuring Head Connection CABLE(14m) for Compu Vision CV-5000

Catalogue number MEASURING HEAD CONNECTION CABLE(14m) for, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

IwavePhoropter

Catalogue number IwavePhoropter, listed by Krypton Vision (Suzhou) Ltd., under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Power Supply Unit for CV-5000 (PC External Type)

2 catalogue numbers from POWER SUPPLY UNIT for CV-5000, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

3nethra

3nethra specto is light weight digital device designed to provide accurate, reliable corrections of refractive errors & visual acuity, , to assist optometrists, ophthalmologists, trained…

Refractor, Manual, Non-Powered, Including Phoropter

Takagi

Catalogue number VIEW TESTER VT-5, listed by Takagi Seiko Co., Ltd., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Ultramatic RX Master Phoropter

2 catalogue numbers from 11635B, listed by Reichert Inc., United States, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Eli Ezer

Digital Refractor Ezer EDR-9000 A

Refractor, Manual, Non-Powered, Including Phoropter

Medizs Digitalized Refractor DR-19

Medizs Digitalized Refractor DR-19 is an automated digital phoropter. Operator can use it to find right eye glasses for patient's vision correction.

Refractor, Manual, Non-Powered, Including Phoropter

S4 Optik

Digital Refractor

Refractor, Manual, Non-Powered, Including Phoropter

Moptim

The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and…

Refractor, Manual, Non-Powered, Including Phoropter

Vision Tester

To measure human being’s myopia, farsightedness, astigmatism, vision balance, esotropia, stereo vision, vision fusion and etc.

Refractor, Manual, Non-Powered, Including Phoropter

SightPilot NAVi Controller SNi-1 Compu Vision CV-5000 Refraction System Chronos

Catalogue number SNi-1, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Visionix

The VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophthalmic device.

Refractor, Manual, Non-Powered, Including Phoropter

LuxVsion

Luxvision Digital Refractor LDR-7800

Refractor, Manual, Non-Powered, Including Phoropter

Lombart

Lombart Black +CYL refractor

Refractor, Manual, Non-Powered, Including Phoropter

Ibex Manual Refractor

Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription.

Refractor, Manual, Non-Powered, Including Phoropter

Vision-R 800

Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability

Refractor, Manual, Non-Powered, Including Phoropter

Refractor

The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER…

Refractor, Manual, Non-Powered, Including Phoropter

Illuminated Phoropter

2 catalogue numbers from 11636, listed by Reichert Inc., United States, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Compu Vision CV-5000

2 catalogue numbers from CV-5000, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Power Supply Unit for CV-5000 (Built-IN PC Type)

2 catalogue numbers from POWER SUPPLY UNIT for CV-5000, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Yeasn

This instrument is applicable with stand and projection for precision measurement of visual functions such as myopia, hyperopia, astigmatism, visual acuity balance, phoria, stereoscopic…

Refractor, Manual, Non-Powered, Including Phoropter

Phoropter VRx

2 catalogue numbers from 16242, listed by Reichert Inc., United States, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Digital Refractor HDR-7000P

Catalogue number HDR-7000P, listed by Huvitz Co., Ltd., South Korea, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.

Refractor, Manual, Non-Powered, Including Phoropter

Vision-R 700

Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability

Refractor, Manual, Non-Powered, Including Phoropter

S4Optik

S4Optik Black -CYL refractor

Refractor, Manual, Non-Powered, Including Phoropter

Advancing Eyecare

For checking the refractive state of human eye.

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