Data / Medical devices / Magnifier, Hand-Held, Low-Vision

Magnifier, Hand-Held, Low-Vision (HJF): 40 FDA-registered makers in 10 countries

Name: FDA-registered makers of Magnifier, Hand-Held, Low-Vision
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

40 establishments in 10 countries are registered with the FDA to make Magnifier, Hand-Held, Low-Vision (product code HJF, Class 1, 21 CFR 886.5540). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 14, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this device Makers in China Watch this device

Product code: HJF
Device class: 1
Regulation: 886.5540
Medical specialty: Ophthalmic

Makers by country

Country	Makers
China	18
United States	5
Taiwan	5
India	5
Germany	2
Philippines	1
Pakistan	1
Vietnam	1
Japan	1
Switzerland	1

Makers of Magnifier, Hand-Held, Low-Vision

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Source
A. Schweizer GMBH	FORCHHEIM Bavaria, Germany	Manufacturer	api.fda.gov
Ambi, Inc.	Capitola, CA, United States	Manufacturer	api.fda.gov
Aurora Optic Inc.	CHIAYI Chiayi(County), Taiwan	Manufacturer	api.fda.gov
Becton Dickinson	Franklin Lakes, NJ, United States	Specification developer	api.fda.gov
Contour Optik Philippine Inc.	Tanza Cavite, Philippines	Manufacturer	api.fda.gov
Contour Optik(jiangxi) Co., Ltd	YINGTAN Jiangxi, China	Manufacturer	api.fda.gov
Contour Optik, Inc.	CHIAYI Chiayi(County), Taiwan	Manufacturer	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	api.fda.gov
Dongguan Guangzhi Glasses Products Co. Ltd.	DONGGUANG Guangdong, China	Manufacturer	api.fda.gov
Enhanced Vision Systems, Inc.	Huntingtn Bch, CA, United States	Specification developer	api.fda.gov
Eschenbach Optik GMBH + Co	Nurnberg Bavaria, Germany	Manufacturer	api.fda.gov
Freedom Scientific BLV Group, LLC.	Clearwater, FL, United States	Manufacturer	api.fda.gov
Faith Eyewear Co., Ltd.	Taizhou City Zhejiang, China	Manufacturer	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Hong Ming Enterprise Co., Ltd.	Taichung City, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	api.fda.gov
ICU Eyecare Solutions Inc.	Hollister, CA, United States	Manufacturer	api.fda.gov
Indo-German Surgical Corporation	Mumbai Maharashtra, India	Exporter to the US, Manufacturer	api.fda.gov
Jiangsu Moen Industrial Co.,ltd	Suqian Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
M/S Tarun Enterprises	Prayagraj, Uttar Pradesh, India	Manufacturer	api.fda.gov
Mingshida (vietnam) International Company Limited	Thuan Thanh Town Bac Ninh, Vietnam	Contract manufacturer, Manufacturer	api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	api.fda.gov
Optica Fukui, Inc.	Sabae City, Fukui Pref., Japan	Manufacturer	api.fda.gov
Paul Instruments (india)	CALCUTTA West Bengal, India	Manufacturer	api.fda.gov
Ruichuangke Digital Co. Ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Ryser Optik AG	St.Gallen Sankt Gallen, Switzerland	Manufacturer	api.fda.gov
Shenzhen Yashiwei Optical Co.,limited	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Sun-Shine Land Intl. Ltd.	Tamsui Taipei, Taiwan	Manufacturer	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Tuper Medical Co., Ltd.	Dezhou City Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
URIT Medical Electronic Co., Ltd.	Guilin Guangxi, China	Manufacturer	api.fda.gov
Valentine Intl. Ltd.	Hsichih City, Taipei Hsien, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Eugenia Eyewear Co., Ltd	WENZHOU Zhejiang, China	Manufacturer	api.fda.gov
Wenzhou Faith Import & Export Co. Ltd.	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Mingshida Light Industrial Products Co., Ltd	Wenzhou Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Wenzhou Outlook Optical Co., Ltd.	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Steed International Industry Co Ltd	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Wonderful Eyewear Co., Ltd	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Outlook Optical Manufactory Co. Ltd	wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zoomax Technology Co., Limited	Hangzhou Zhejiang, China	Complaint file establishment, Contract sterilizer, Exporter to the US, Foreign private label distributor, Remanufacturer, Repackager or relabeler, Reprocessor	api.fda.gov

Updated June 14, 1982. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.