FDA Registration
Active
🇨🇳 China
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Reg #: 3010610157
·
FEI: 3010610157
·
Expires 2026
Products
11
Proprietary Names
17
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
- Registration Number
- 3010610157
- FEI Number
- 3010610157
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 35-2,YingTian GuangDian GongGu,CaiJiaGang Industrial Zone, BeiBei District
- City
- Chongqing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191314
Owner / Operator
- Firm Name
- Chongqing Sunkingdom Medical Instrument Co.,Ltd
- Operator Number
- 10045593
- Address
- 35-2,YingTianGuangDianGongGu,CaiJiaGang, Industrial Zone
- City
- Chongqing
- State
- CN-CQ
- Postal Code
- 400070
- Country
- CN
- Correspondent
- JunHua He
US Agent
- Business Name
- HYUN TURLE E-COMMERCE INC
- Contact Name
- yun chen
- Address
- Monterey Park
- City
- Monterey Park
- State
- CA
- ZIP
- 91755
- Country
- US
- [email protected]
- Phone
- 626 6783399
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2018-11-16 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2022-12-07 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2019-12-20 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2018-05-24 |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | Class 2 | Ophthalmic | No | 2017-07-10 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2013-12-05 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2024-08-01 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2018-11-25 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-01-16 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-01-16 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2024-03-20 |
Proprietary Names
Sunkingdom Fundus Camera SK-650A, SK-650B, SK-660A, SK-680A, SK-680B, SK-680C;Sunkingdom Ocular Surface Analyzer DA-3
Retinometer SK-6500A,SK-6500B
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
Sunkingdom Lensmeter SK-1000A, SK-1000B
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-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
SlitLamp LS-6C,LS-7C,LS-7CS,LS-7CE,LS-8A,LS-9CS
Sunkingdom Perimeter SK-850A, SK-850AS, SK-850AE, SK-850B, SK-850C, SK-950B, SK-950C
Eye Refractometer
Auto Ref/Keratometer
Kerato refractometer
SK-6800A,SK-6800B
Ophlthalmic Refractometer
Sunkingdom Ophthalmic Slit Lamp Microscope LS-1A,LS-1B
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
Corneal Topographer SK-7000A,SK-7000B
Establishment Types
Manufacture Medical Device