Chongqing Sunkingdom Medical Instrument Co.,Ltd
Chongqing, CN
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD appears in FDA device records in Chongqing, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Chongqing Sunkingdom Medical Instrument Co.,Ltd between 2018 and 2023. The busiest year on record is 2018, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P | IYO | Substantially Equivalent | |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | HKY | Substantially Equivalent | |
| K182306 | Sunkingdom Slit Lamp | HJO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010610157 | 3010610157 | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | No. 2, Building 23, No. 101, Jiade Avenue, Shijialiang Town, Chongqing 400707 CN | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt
- PJZCamera, Ophthalmic, General-Use
- HOXChart, Visual Acuity
- HLMInstrument, Measuring, Lens, Ac-Powered
- HPTPerimeter, Automatic, Ac-Powered
- HKORefractometer, Ophthalmic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HKYTonometer, Manual
- MMQTopographer, Corneal, Ac-Powered
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain