Chongqing Sunkingdom Medical Instrument Co., Ltd.
Manufacturer and brand owner in Chongqing, China. 11 device types, 12 products catalogued, 3 clearances.
Chongqing Sunkingdom Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Tonometer, Manual, Chart, Visual Acuity and 9 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
11device types registered with the FDA
12products catalogued under its own name
3510(k) clearances
Registration
| Registered name | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010610157 |
| FEI number | 3010610157 |
| DUNS | 545824560 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 重庆上邦医疗设备有限公司 |
|---|---|
| Unified social credit code | 915001097874714975 |
| Source | NMPA UDI database |
Location
| City | Chongqing |
|---|---|
| Province | Chongqing |
| Address | 35-2,YingTian GuangDian GongGu,CaiJiaGang Industrial Zone |
| Postal code | 400000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | Class 2 | Sunkingdom Ophthalmic Slit Lamp Microscope LS-1A,LS-1B | 2018 | 7 |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | Class 2 | SlitLamp LS-3,LS-4,LS-5,LS-5C,LS-6,LS-7,LS-7DS,LS-7DE,LS-8,LS-8C,LS-8D,LS-9,LS-9C,LS-9D;OcularsurfaceAnalyzer DA-1,DA-2, SlitlampLS-3,LS-4,LS-5,LS-5C,LS-6,LS-7,LS-7DS,LS-7DE,LS-8,LS-8C,LS-8D,LS-9,LS-9C,LS-9D;OcularsurfaceAnalyzerDA-1,DA-2, SlitLamp LS-6C,LS-7C,LS-7CS,LS-7CE,LS-8A,LS-9CS | 2017 | 12 |
| Camera, Ophthalmic, General-Use | Class 2 | Sunkingdom Fundus Camera SK-650A, SK-650B, SK-660A, SK-680A, SK-680B, SK-680C;Sunkingdom Ocular Surface Analyzer DA-3 | 2018 | 14 |
| Chart, Visual Acuity | Class 1 | Retinometer SK-6500A,SK-6500B | 2022 | 21 |
| Instrument, Measuring, Lens, Ac-Powered | Class 1 | Sunkingdom Lensmeter SK-1000A, SK-1000B | 2018 | 15 |
| Perimeter, Automatic, Ac-Powered | Class 1 | Sunkingdom Perimeter SK-850A, SK-850AS, SK-850AE, SK-850B, SK-850C, SK-950B, SK-950C | 2013 | 7 |
| Refractometer, Ophthalmic | Class 1 | Auto Ref/Keratometer, SK-6800A,SK-6800B, Ophlthalmic Refractometer, Eye Refractometer, Kerato refractometer | 2024 | 17 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A SK-3000B, SK-3000C,SK-2000AP, SK-2000A,SK-2000P, Ophthalmic Ultrasound Examination Instrument SK-3000A SK-3000B, SK-3000C,SK-2000AP, SK-2000A,SK-2000P | 2023 | 37 |
| Tonometer, Manual | Class 2 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | 2019 | 5 |
| Topographer, Corneal, Ac-Powered | Class 1 | Corneal Topographer SK-7000A,SK-7000B | 2024 | 5 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A SK-3000B, SK-3000C,SK-2000AP, SK-2000A,SK-2000P, Ophthalmic Ultrasound Examination Instrument SK-3000A SK-3000B, SK-3000C,SK-2000AP, SK-2000A,SK-2000P | 2023 | 44 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Ophthalmic Slit Lamp Microscope | PUE | 20 |
| Perimeter | HPT | 7 |
| Ophthalmic Ultrasound Examination Instrument | IYO | 6 |
| Fundus Camera | PJZ | 6 |
| Applanation Tonometer | HKY | 3 |
| Ocular Surface Analyzer | PUE | 2 |
| Kerato refractometer | HKO | 2 |
| Lensmeter | HLM | 2 |
| Sunkingdom Retinometer | HOX | 2 |
| Corneal Topographer | MMQ | 2 |
| Ophthalmic Slit Lamp Microscope | HJO | 2 |
| Ocular Surface Analyzer | PJZ | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222787 | 2023-01-09 | IYO | Traditional | This company |
| K191314 | 2019-12-19 | HKY | Traditional | This company |
| K182306 | 2018-11-22 | HJO | Traditional | This company |
Nearby Manufacturers
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.