Taizhou City K&W International Trade Co., Ltd.
Registered establishment in Jiangyan, Jiangsu, China. 38 device types.
Taizhou City K&W International Trade Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Lens, Maddox, Exophthalmometer and 36 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005785090 |
| FEI number | 3005785090 |
| Establishment type | Repacker / relabeller, Exporter |
Chinese Registration
| Chinese legal name | 泰州市匡威国际贸易有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Jiangyan |
|---|---|
| Province | Jiangsu |
| Address | NO.6 JINXIN GARDEN LUOTANG SUB-DISTRICT |
| Postal code | 225500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | Class 2 | Slit Lamp | 2015 | 7 |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | Class 2 | Digital Hand-held Slit Lamp | 2018 | 12 |
| Camera, Ophthalmic, Ac-Powered | Class 2 | Retina Camera | 2023 | 3 |
| Camera, Ophthalmic, General-Use | Class 2 | Hand-held Fundus Camera | 2018 | 14 |
| Chair, Ophthalmic, Ac-Powered | Class 1 | Ophthalmic Chair | 2015 | 6 |
| Chart, Visual Acuity | Class 1 | Vision Chart | 2015 | 21 |
| Clip, Lens, Trial, Ophthalmic | Class 1 | Trial Clip | 2015 | 3 |
| Continuous Measurement Thermometer | Class 2 | Non-contact infrared thermometer | 2020 | 115 |
| Exophthalmometer | Class 1 | Exophthalmometer | 2015 | 6 |
| Frame, Trial, Ophthalmic | Class 1 | Ophthalmic & Ophthalmology, Trial Frame | 2015 | 9 |
| Gauge, Lens, Ophthalmic | Class 1 | Lens Clock; Radian Aparatus | 2015 | 9 |
| Instrument, Measuring, Lens, Ac-Powered | Class 1 | Lensmeter | 2012 | 15 |
| Keratoscope, Ac-Powered | Class 1 | Keratometer | 2015 | 2 |
| Keratoscope, Battery-Powered | Class 1 | Hand-held Keratometer; Portable Keratometer | 2015 | 3 |
| Lens, Condensing, Diagnostic | Class 1 | Diopter Lens; Retina Lens; Aspheric Lens; Bio Lens;Slit Lamp Lens;Non-contact Surgical Lens;Retinal Scale | 2015 | 6 |
| Lens, Maddox | Class 1 | Maddox Lens | 2015 | 2 |
| Lens, Spectacle, Non-Custom (Prescription) | Class 1 | Confirmation Test | 2015 | 263 |
| Microscope, Operating, Non-Electric, Ophthalmic | Class 1 | Microscope, Operating, NON-Electric, Ophthalmic | 2012 | 1 |
| Monitor, Eye Movement | Class 2 | Ophthalmoscope | 2015 | 2 |
| Ophthalmoscope, Battery-Powered | Class 2 | Ophthalmoscope | 2015 | 11 |
| Perimeter, Automatic, Ac-Powered | Class 1 | Perimeter | 2018 | 7 |
| Prism, Bar, Ophthalmic | Class 1 | Ophthalmic Prism Bar | 2015 | 6 |
| Projector, Ophthalmic | Class 1 | Projector, Ophthalmic | 2012 | 11 |
| Pupillometer, Manual | Class 1 | Pupillometer, Manual | 2012 | 9 |
| Rack, Skiascopic | Class 1 | Retinoscope Rack; Skiascopic Rack | 2015 | 4 |
| Refractometer, Ophthalmic | Class 1 | Refractometer, Ophthalmic | 2012 | 17 |
| Refractor, Manual, Non-Powered, Including Phoropter | Class 1 | Refractor, Manual, NON-Powered | 2012 | 15 |
| Retinoscope, Battery-Powered | Class 1 | Retinoscope | 2015 | 8 |
| Set, Lens, Trial, Ophthalmic | Class 1 | SET, Lens, Trial, Ophthalmic | 2012 | 13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Occluder | 2015 | 384 |
| Simulatan (Including Crossed Cylinder) | Class 1 | Cross Cylinder | 2015 | 2 |
| Source, Carrier, Fiberoptic Light | Class 1 | Source, Carrier, Fiberoptic Light | 2012 | 6 |
| Stand, Instrument, Ac-Powered, Ophthalmic | Class 1 | Stand, Instrument, AC-Powered, Ophthalmic | 2012 | 5 |
| Sunglasses (Non-Prescription Including Photosensitive) | Class 1 | Sunglasses | 2009 | 522 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Ultrasonic Biometer, Ultrasonic A/B Scan | 2018 | 37 |
| Table, Instrument, Powered, Ophthalmic | Class 1 | Table, Instrument, Powered, Ophthalmic, Instrument Table | 2012 | 12 |
| Tonometer, Manual | Class 2 | Applanation Tonometer | 2018 | 5 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Ultrasonic Biometer, Ultrasonic A/B Scan | 2018 | 44 |
Clearances
No clearance names Taizhou City K&W International Trade Co., Ltd. as applicant. 7 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K190954 | 2020-01-22 | HKI | Traditional | Chongqing BIO Newvision Medical Equipment Ltd. |
| K180207 | 2018-11-28 | FLL | Traditional | Alicn Medical Shenzhen, Inc |
| K142263 | 2016-04-15 | HKY | Traditional | Shanghai Mediworks Precision Instruments Co., Ltd. |
| K152318 | 2015-11-17 | IYO | Traditional | Meda Co., Ltd. |
| K121243 | 2013-05-03 | IYO | Traditional | Meda Co., Ltd. |
| K100439 | 2010-07-16 | HJO | Traditional | Shanghai Mediworks Precision Instruments Co., Ltd. |
| K052599 | 2006-11-07 | HLJ | Traditional | Suzhou 66 Vision Tech Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | 19 |
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.
The manufacturer named here can complete this record.