S4 Optik

S4OPTIK Ophthalmic Examination Chair - Model 2000-CH-H-FIX

Registry build 21.09.26
6manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HME
Manufacturer City Province Registered as Device types
Wuxi Zontai Int’l Corporation Ltd. Wuxi Jiangsu Contract manufacturer 22
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Taiyuan Shaanxi Contract manufacturer 14
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
Shanghai Canton Optics Equipment Co., Ltd. Shanghai Shanghai Manufacturer 14
Visuscience Meditech Co., Ltd. Wuxi Jiangsu Specification developer 9

Record

Regulatory record for S4 Optik
Listed by Innova Medical Ophthalmics, Canada
FDA product code HME
Device type Chair, Ophthalmic, Ac-Powered
Device class Class 1
Regulation 21 CFR 886.1140
Establishment Exporter
Premarket notification Exempt
Record published 2025-02-20
Record revised 2026-01-27 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for S4 Optik
Catalogue number Size Status
2500-CB-H In distribution
ETILT-CH-H-S4 In distribution
2000-CB-H In distribution
2500-CH-H In distribution
222-001 In distribution
1000-CB-H In distribution
281-000 In distribution
2000-CH-H-FIX In distribution
2000-CH-H-CUS In distribution
2000-CH-H In distribution
2000-CB-H-L In distribution
1000-CB-H-L In distribution
280-000 In distribution
2500-CB-H-L In distribution
1000-CH-H In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OC-2200 Topcon Corp. 105
OC-2300 Topcon Corp. 52
OC-2400 Topcon Corp. 21
Reliance Haag-Streit USA, Inc. 15
Ufsk-Osys Surgeon’s chair Ufsk-International Osys Gmbh 8
Marco Takagi Seiko Co., Ltd. 6
Ufsk-Osys Treatment chair Ufsk-International Osys Gmbh 4
Topcon Antoni Carles SA 4
Lombart Innova Medical Ophthalmics 2
Marco Innova Medical Ophthalmics 2
Illuminix Illuminix Industries LLC 1
Surgical Table MDT SP. Z O.O. 1

Showing 12 of 14. All products under Chair, Ophthalmic, 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