FDA Registration
Active
🇨🇳 China
TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD.
Reg #: 3005785090
·
FEI: 3005785090
·
Expires 2026
Products
38
Proprietary Names
38
Establishment Types
2
Classifications
38
Registration Details
- Registration Name
- TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD.
- Registration Number
- 3005785090
- FEI Number
- 3005785090
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.6 JINXIN GARDEN LUOTANG SUB-DISTRICT
- City
- Jiangyan Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K142263
Owner / Operator
- Firm Name
- TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD.
- Operator Number
- 10029678
- Address
- NO.6 JINXIN GARDEN LUOTANG SUB-DISTRICT
- City
- Jiangyan
- State
- Jiangsu
- Postal Code
- 225500
- Country
- CN
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Rdg
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2012-03-22 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2015-01-29 |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | Class 1 | Ophthalmic | No | 2012-03-22 |
| Simulatan (Including Crossed Cylinder) | HOR | Class 1 | Ophthalmic | No | 2015-01-29 |
| Clip, Lens, Trial, Ophthalmic | HPB | Class 1 | Ophthalmic | No | 2015-01-29 |
| Rack, Skiascopic | HMH | Class 1 | Ophthalmic | No | 2015-01-29 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2015-01-29 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2018-06-12 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2012-03-22 |
| Chair, Ophthalmic, Ac-Powered | HME | Class 1 | Ophthalmic | No | 2015-01-29 |
| Keratoscope, Ac-Powered | HLQ | Class 1 | Ophthalmic | No | 2015-01-29 |
| Lens, Maddox | HKR | Class 1 | Ophthalmic | No | 2015-01-29 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2012-03-22 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2012-03-22 |
| Microscope, Operating, Non-Electric, Ophthalmic | HRB | Class 1 | General, Plastic Surgery | No | 2012-03-22 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2018-06-12 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-06-12 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2015-01-14 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2018-02-03 |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | Class 2 | Ophthalmic | No | 2018-02-03 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2012-03-22 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2015-01-29 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2015-01-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-24 |
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2012-03-22 |
| Prism, Bar, Ophthalmic | HKW | Class 1 | Ophthalmic | No | 2015-01-29 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2015-01-27 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2009-06-12 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2015-01-29 |
| Monitor, Eye Movement | HLL | Class 2 | Ophthalmic | No | 2015-01-29 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2015-01-29 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2012-03-22 |
| Retinoscope, Battery-Powered | HKM | Class 1 | Ophthalmic | No | 2015-01-29 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2023-05-17 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2018-02-03 |
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2012-03-22 |
| Exophthalmometer | HLS | Class 1 | Ophthalmic | No | 2015-01-29 |
| Keratoscope, Battery-Powered | HLR | Class 1 | Ophthalmic | No | 2015-01-29 |
Proprietary Names
LENSMETER
Confirmation Test
STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC
Cross Cylinder
Trial Clip
Retinoscope Rack; Skiascopic Rack
Occluder
APPLANATION TONOMETER
REFRACTOMETER, OPHTHALMIC
Ophthalmic Chair
Keratometer
Maddox Lens
SOURCE, CARRIER, FIBEROPTIC LIGHT
TABLE, INSTRUMENT, POWERED, OPHTHALMIC
Instrument Table
MICROSCOPE, OPERATING, NON-ELECTRIC, OPHTHALMIC
Ultrasonic Biometer
OPHTHALMIC & OPHTHALMOLOGY, TRIAL FRAME
Hand-held Fundus Camera
Digital Hand-held Slit Lamp
SET, LENS, TRIAL, OPHTHALMIC
Lens Clock; Radian Aparatus
Ultrasonic A/B Scan
Vision Chart
Non-contact infrared thermometer
PROJECTOR, OPHTHALMIC
Ophthalmic Prism Bar
Slit Lamp
SUNGLASSES
OPHTHALMOSCOPE
Diopter Lens; Retina Lens; Aspheric Lens; Bio Lens;Slit Lamp Lens;Non-contact Surgical Lens;Retinal Scale
REFRACTOR, MANUAL, NON-POWERED
Retinoscope
Retina Camera
Perimeter
PUPILLOMETER, MANUAL
EXOPHTHALMOMETER
Hand-held Keratometer; Portable Keratometer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device