S4 Optik

Applanation Tonometer

Registry build 21.09.26
5manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).

Chinese manufacturers registered for FDA product code HKY
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
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
Shanghai Mediworks Precision Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 13
Chongqing Sunkingdom Medical Instrument Co., Ltd. Chongqing Chongqing Manufacturer 11

Record

Regulatory record for S4 Optik
Listed by Costruzioni Strumenti Oftalmici C.S.O. SRL
FDA product code HKY
Device type Tonometer, Manual
Device class Class 2
Regulation 21 CFR 886.1930
510(k) K022054
Record published 2020-12-14

Specifications

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

Catalogue Numbers

Catalogue numbers for S4 Optik
Catalogue number Size Status
TONOMETER A900 In distribution
TONOMETER F900 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tonometer AT 900 Haag-Streit AG 7
Ambler Surgical Ambler Surgical, LLC 7
Ocu-Film® +” Reichert Inc. 5
Bausch + Lomb Bausch & Lomb Incorporated 5
AccuTip Cover Accutome, Inc. 4
Mediworks Shanghai Mediworks Precision Instruments Co., Ltd. 4
Applanation Tonometer Chongqing Sunkingdom Medical Instrument Co., Ltd. 3
Icare ic200 Icare Finland Oy 3
Marco Takagi Seiko Co., Ltd. 2
iCare PATIENT2 Icare Finland Oy 2
Tonometer AT 870 Haag-Streit AG 2
Takagi Takagi Seiko Co., Ltd. 2

Showing 12 of 71. All products under Tonometer, Manual

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