Data / Medical devices / Table, Instrument, Powered, Ophthalmic

Table, Instrument, Powered, Ophthalmic (HRJ): 40 FDA-registered makers in 15 countries

Name: FDA-registered makers of Table, Instrument, Powered, Ophthalmic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

40 establishments in 15 countries are registered with the FDA to make Table, Instrument, Powered, Ophthalmic (product code HRJ, Class 1, 21 CFR 886.4855). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on July 6, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: HRJ
Device class: 1
Regulation: 886.4855
Medical specialty: Ophthalmic

Makers by country

Country	Makers
China	9
Germany	6
United States	5
Japan	5
India	4
Poland	2
Spain	1
Brazil	1
Canada	1
Italy	1
United Kingdom	1
Australia	1
South Korea	1
Taiwan	1
Lithuania	1

Makers of Table, Instrument, Powered, Ophthalmic

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
AKRUS GmbH & Co. KG	Elmshorn Schleswig-Holstein, Germany	Manufacturer	api.fda.gov
Antoni Carles, S.A.	VILASSAR DE MAR Barcelona, Spain	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Apramed Industria E Comercio De Aparelhos Medicos Ltda	SAO CARLOS Sao Paulo, Brazil	Manufacturer	api.fda.gov
Blue.s4	Belleville Ontario, Canada	Manufacturer	api.fda.gov
C.S.O. S.R.L.	Scandicci Firenze, Italy	Manufacturer	api.fda.gov
Carl Zeiss Meditec Inc	Dublin, CA, United States	Manufacturer	api.fda.gov
CX Engineering SP. Z O.O.	Balice Malopolskie, Poland	Contract manufacturer, Manufacturer	api.fda.gov
Endonest Medical Systems LLP	PALGHAR Maharashtra, India	Manufacturer	api.fda.gov
Ergo-Tec GMBH	Wilhelmsdorf Bavaria, Germany	Manufacturer	api.fda.gov
Evans (instruments) Limited	Thetford, Norfolk England, United Kingdom	Manufacturer	api.fda.gov
Ellex Medical Pty Ltd	Mawson Lakes South Australia, Australia	Manufacturer	api.fda.gov
Gino Optical (shanghai) Co., Ltd.	Shanghai, China	Exporter to the US, Manufacturer	api.fda.gov
Hanson & Zollinger Inc	Berlin, NJ, United States	Contract manufacturer, Repackager or relabeler	api.fda.gov
HS Doms GMBH	Saalfeld Thuringia, Germany	Manufacturer	api.fda.gov
Huvitz Co., Ltd.	Anyang-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Langfang Far East Prosperous Optical Instrument Co.,ltd.	Langfang Hebei, China	Contract manufacturer, Manufacturer	api.fda.gov
Lianyungang Tiannuo Optical Instrument Co., Ltd.	LIANYUNGANG Jiangsu, China	Contract manufacturer, Repackager or relabeler	api.fda.gov
Lightmed Corp.	New Taipei City, Taiwan	Manufacturer	api.fda.gov
M/S Tarun Enterprises	Prayagraj, Uttar Pradesh, India	Manufacturer	api.fda.gov
MDT SP. Z O.O.	KRAKOW Malopolskie, Poland	Manufacturer	api.fda.gov
Medinstrus UAB	MAZEIKIU R Mazeikiai, Lithuania	Contract manufacturer, Manufacturer, Remanufacturer	api.fda.gov
Myvision Medical Pvt. Ltd.	Ahmedabad Gujarat, India	Manufacturer	api.fda.gov
Nidek Co., Ltd.	Gamagori, Aichi, Japan	Specification developer	api.fda.gov
Nidek Co., Ltd. Hamacho Plant	Gamagori, Aichi, Japan	Manufacturer	api.fda.gov
Nidek Incorporated	The Colony, TX, United States	Manufacturer	api.fda.gov
Ningbo Ming Sing Optical R&D Co., Ltd.	Ningbo Zhejiang, China	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Oculus Optikgerate GMBH	WETZLAR Hesse, Germany	Manufacturer	api.fda.gov
Ray Vision Inc.	Lake Forest, CA, United States	Repackager or relabeler, Specification developer	api.fda.gov
Shanghai Canton Optics Equipment Co., Ltd.	Shanghai, China	Exporter to the US, Manufacturer	api.fda.gov
Shanghai Link Instruments Co.,ltd	Changzhou City Jiangsu, China	Manufacturer	api.fda.gov
Shanghai Mediworks Precision Instruments Co., Ltd.	Shanghai, China	Manufacturer	api.fda.gov
Speedway	India Delhi, India	Manufacturer	api.fda.gov
Takagi Seiko Co., Ltd.	NAKANO-SHI Nagano, Japan	Exporter to the US, Manufacturer	api.fda.gov
Topcon Corp.	Tokyo, Japan	Specification developer	api.fda.gov
Towa Medical Instruments Co.,ltd.	Nakano-shi Nagano, Japan	Contract manufacturer, Manufacturer	api.fda.gov
Taiyuan North China Xinyuan Tech. Center (Co., LTD.)	TAIYUAN Shaanxi, China	Contract manufacturer, Manufacturer	api.fda.gov
Topcon Healthcare, Inc.	Oakland, NJ, United States	Specification developer	api.fda.gov
WAVELIGHT GmbH	ERLANGEN Bavaria, Germany	Specification developer	api.fda.gov
WAVELIGHT GmbH	PRESSATH Bavaria, Germany	Manufacturer	api.fda.gov
Wuxi Zontai Int'l Corporation Ltd.	WUXI Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov

Updated July 6, 1993. 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.