Data / Medical devices / China / Taizhou City K&W International Trade Co.,ltd.
Taizhou City K&W International Trade Co.,ltd.: FDA-registered device maker in Jiangyan Jiangsu, China, 7 510(k) clearances
Taizhou City K&W International Trade Co.,ltd. is registered with the FDA (registration 3005785090) in Jiangyan Jiangsu, China. It lists 38 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 22, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005785090
- Address
- No.6 Jinxin Garden Luotang Sub-District, Jiangyan Jiangsu, China, 225500
- Owner or operator
- TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. (10029678)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- June 12, 2009
- Registered through
- 2026
- Brand names listed
- APPLANATION TONOMETER, Confirmation Test, Cross Cylinder, Digital Hand-held Slit Lamp, Diopter Lens; Retina Lens; Aspheric Lens; Bio Lens;Slit Lamp Lens;Non-contact Surgical Lens;Retinal Scale, EXOPHTHALMOMETER, Hand-held Fundus Camera, Hand-held Keratometer; Portable Keratometer and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2020 | K190954 | Fundus Camera | HKI | Substantially Equivalent | Chongqing Bio Newvision Medical Equipment , Ltd. | accessdata.fda.gov |
| November 28, 2018 | K180207 | Non-contact Infrared Thermometer | FLL | Substantially Equivalent | Alicn Medical (Shenzhen), Inc. | accessdata.fda.gov |
| April 15, 2016 | K142263 | Applanation Tonometer | HKY | Substantially Equivalent | Shanghai Mediworks Precision Instruments Co. , Ltd. | accessdata.fda.gov |
| November 17, 2015 | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | IYO | Substantially Equivalent | MEDA Co., Ltd. | accessdata.fda.gov |
| May 3, 2013 | K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | IYO | Substantially Equivalent | MEDA Co., Ltd. | accessdata.fda.gov |
| July 16, 2010 | K100439 | MEDIWORKS SLIT LAMP | HJO | Substantially Equivalent | Shanghai Mediworks Precision Instruments Co. , Ltd. | accessdata.fda.gov |
| November 7, 2006 | K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | HLJ | Substantially Equivalent | Suzhou 66 Vision Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Keratoscope, Ac-Powered
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- All makers of Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Gauge, Lens, Ophthalmic
- All makers of Pupillometer, Manual
Updated January 22, 2020. 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.