Shanghai Link Instruments Co., Ltd.

Registered establishment in Changzhou, Jiangsu, China. 21 device types.

Registry build 21.09.26

Shanghai Link Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Suit, Surgical and 19 other device types. Its earliest product listing with the FDA dates from 2017.

Registration

FDA registration record for Shanghai Link Instruments Co., Ltd.
Registered name SHANGHAI LINK INSTRUMENTS CO.,LTD
Status Registered
Registration expires 2026
Registration number 3010774780
FEI number 3010774780
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Shanghai Link Instruments Co., Ltd.
Chinese legal name 該公司类别属于私人股份有限公司
Source Hong Kong company register lookup

Location

Address of Shanghai Link Instruments Co., Ltd.
City Changzhou
Province Jiangsu
Address 5th Floor, Building 1, No. 17, Beitanghe East Road, Tianning District
Postal code 213000
Country China

What It Makes

Device types Shanghai Link Instruments Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 Face Mask 2020 439
Camera, Ophthalmic, General-Use Class 2 Hand-held Fundus camera 2019 14
Cart, Emergency, Cardiopulmonary (Excluding Equipment) Class 1 Medical Trolley 2021 34
Chart, Visual Acuity Class 1 Chart 2019 21
Cleaner, Ultrasonic, Medical Instrument Class 1 Ultrasonic Cleaner 2021 48
Device, Measuring, Lens Radius, Ophthalmic Class 1 Frame Heater; Auto Lens Edger 2021 5
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Class N Face Mask 2020 182
Instrument, Measuring, Lens, Ac-Powered Class 1 Auto lensmeter 2019 15
Light, Examination, Medical, Battery Powered Class 1 Slit- Lamp 2019 53
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 Operation Microscope 2019 12
Ophthalmoscope, Ac-Powered Class 2 Optical Coherence Tomography, Ophthalmoscope 2024 7
Otoscope Class 1 Otoscope, Otoscope Wall Mount System 2024 43
Perimeter, Ac-Powered Class 1 Perimeter 2019 1
Pupillometer, Manual Class 1 PD Meter 2019 9
Refractometer, Ophthalmic Class 1 Auto refractometer, Vision Screener 2019 17
Refractor, Manual, Non-Powered, Including Phoropter Class 1 Phoropter 2019 15
Set, Lens, Trial, Ophthalmic Class 1 Trial lens set 2019 13
Suit, Surgical Class 1 Face Mask 2020 74
Sunglasses (Non-Prescription Including Photosensitive) Class 1 Smart Glasses 2025 522
Table, Instrument, Powered, Ophthalmic Class 1 Ophthalmic instrument table, Ophthalmic Chair and Stand Unit 2017 12
Thermometer Kit Class 2 Thermometer 2020 11

From the Company

Published by the company on its own website, not by the FDA.

Information published by Shanghai Link Instruments Co., Ltd.
Founded 2009
Factory area 1885 m²
Main products Auto Refractometers, Phoropters, Slit Lamps, Optical Lab Machinery, Ophthalmic diagnostic equipment
Certifications FDA, CE, ISO 9001, ISO 13485
Export markets 80+ countries
OEM and ODM Offered

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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer