Data / Medical devices / China / Chongqing Sunkingdom Medical Instrument Co.,ltd
Chongqing Sunkingdom Medical Instrument Co.,ltd: FDA-registered device maker in Chongqing, China, 3 510(k) clearances
Chongqing Sunkingdom Medical Instrument Co.,ltd is registered with the FDA (registration 3010610157) in Chongqing, China. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 9, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010610157
- Address
- No. 2, Building 23, No. 101, Jiade Avenue, Shijialiang Town Liangjiang New District, Chongqing, China, 400707
- Owner or operator
- Chongqing Sunkingdom Medical Instrument Co.,Ltd (10045593)
- Roles
- Manufacturer
- First device listed
- December 5, 2013
- Registered through
- 2027
- Brand names listed
- Auto Ref/Keratometer, Corneal Topographer SK-7000A,SK-7000B, Eye Refractometer, Kerato refractometer, Ophlthalmic Refractometer, Ophthalmic Ultrasound Examination Instrument SK-3000A SK-3000B, SK-3000C,SK-2000AP, SK-2000A,SK-2000P, Retinometer SK-6500A,SK-6500B, SK-6800A,SK-6800B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Manufacturer | accessdata.fda.gov |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Ophthalmic, General-Use | PJZ | 2 | Manufacturer | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Manufacturer | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Manufacturer | accessdata.fda.gov |
| Refractometer, Ophthalmic | HKO | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Manufacturer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
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 9, 2023 | K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P | IYO | Substantially Equivalent | Chongqing Sunkingdom Medical Instrument Co., Ltd. | accessdata.fda.gov |
| December 19, 2019 | K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | HKY | Substantially Equivalent | Chongqing Sunkingdom Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 22, 2018 | K182306 | Sunkingdom Slit Lamp | HJO | Substantially Equivalent | Chongqing Sunkingdom Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Chart, Visual Acuity
- All makers of Biomicroscope, Slit-Lamp, Ac-Powered
- All makers of Camera, Ophthalmic, General-Use
- All makers of Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Refractometer, Ophthalmic
Updated January 9, 2023. 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.