FDA Registration
Active
🇨🇳 China
SHANGHAI LINK INSTRUMENTS CO.,LTD
Reg #: 3010774780
·
FEI: 3010774780
·
Expires 2026
Products
21
Proprietary Names
19
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- SHANGHAI LINK INSTRUMENTS CO.,LTD
- Registration Number
- 3010774780
- FEI Number
- 3010774780
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5th Floor, Building 1, No. 17, Beitanghe East Road, Tianning District
- City
- Changzhou City Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- SHANGHAI LINK INSTRUMENTS CO.,LTD
- Operator Number
- 10053961
- Address
- 5th Floor, Building 1, No. 17, Beitanghe East Road, Tianning District
- City
- Changzhou City
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
- Correspondent
- Xiaoli Sun
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2019-02-09 |
| Perimeter, Ac-Powered | HOO | Class 1 | Ophthalmic | No | 2019-12-17 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2019-12-17 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2019-02-09 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 2021-12-24 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2019-12-17 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2019-02-09 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2017-01-31 |
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2019-02-09 |
| Thermometer Kit | PXH | Class 2 | General Hospital | No | 2020-03-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-05-20 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2024-04-09 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2024-08-26 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2025-03-06 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2021-12-24 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2019-02-09 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2019-02-09 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2021-12-24 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2019-02-09 |
Proprietary Names
Auto lensmeter
Perimeter
Trial lens set
Phoropter
Frame Heater; Auto Lens Edger
Operation Microscope
Auto refractometer, Vision Screener
Ophthalmic instrument table, Ophthalmic Chair and Stand Unit
PD Meter
Thermometer
Face Mask
Optical Coherence Tomography, Ophthalmoscope
Otoscope, Otoscope Wall Mount System
Smart Glasses
Medical Trolley
Chart
Slit- Lamp
Ultrasonic Cleaner
Hand-held Fundus camera
Establishment Types
Manufacture Medical Device