Shanghai Mediworks Precision Instruments Co., Ltd.

Manufacturer and brand owner in Shanghai, China. 13 device types, 9 products catalogued, 3 clearances.

Registry build 21.09.26

Shanghai Mediworks Precision Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Tonometer, Manual, Chart, Visual Acuity and 11 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.

13device types registered with the FDA
9products catalogued under its own name
3510(k) clearances

Registration

FDA registration record for Shanghai Mediworks Precision Instruments Co., Ltd.
Registered name SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD.
Status Registered
Registration expires 2026
Registration number 3005755367
FEI number 3005755367
DUNS 527884077
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Shanghai Mediworks Precision Instruments Co., Ltd.
Chinese legal name 上海美沃精密仪器股份有限公司
Unified social credit code 91310112768789926K
Source NMPA UDI database

Location

Address of Shanghai Mediworks Precision Instruments Co., Ltd.
City Shanghai
Province Shanghai
Address No.7, MingPu Phase II, No.3279
Postal code 201100
Country China

What It Makes

Device types Shanghai Mediworks Precision Instruments Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Biomicroscope, Slit-Lamp, Ac-Powered Class 2 Slit Lamp Microscopes 2016 7
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt Class 2 Portable Slit Lamps S150 2017 12
Camera, Ophthalmic, Ac-Powered Class 2 Resolve Fundus Camera 2025 3
Camera, Ophthalmic, General-Use Class 2 Automatic Fundus Camera FC162, Hand-held Fundus Camera FC160 FC161 2016 14
Chart, Visual Acuity Class 1 Vision Charts C901 2009 21
Lens, Condensing, Diagnostic Class 1 Retina Lens 20D 78D 90D 2009 6
Medical Device Data System Class 1 Digital Camera Module Kit DM390,DS650 2025 11
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 Surgical Microscopes SM610 SM620 SM622C SM629F SM626M SM628S SM625D SM623D SM621 SM660 2015 12
Microscope, Surgical, General & Plastic Surgery Class 1 StereOptic Inverter600A;Fundus Viewing System600B 2025 11
Refractometer, Ophthalmic Class 1 Vision screeners V100 V101 V102, Ophthalmic RefractometerV100 V101 V102 2013 17
Table, Instrument, Powered, Ophthalmic Class 1 Instrument table 2013 12
Tonometer, Manual Class 2 Applanation Tonometers 2016 5
Topographer, Corneal, Ac-Powered Class 1 Anterior segment analyzer Scansys TA517, Corneal Topographer DEA520, Three-dimensional Analysis Systems for the Anterior Eye Segment Scansys TA517, Slitlamp biomicroscope Scansys TA517 2019 5

Own-Brand Listings

Devices catalogued by Shanghai Mediworks Precision Instruments Co., Ltd.
Product Code Catalogue numbers
MediWorks HJO 30
Mediworks HKY 4
Mediworks HJL 3
MediWorks HKO 3
Mediworks HRM 3
Mediworks PJZ 3
Mediworks MMQ 2
Mediworks HOX 1
Mediworks PUE 1

Clearances

510(k) clearances naming Shanghai Mediworks Precision Instruments Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K152429 2016-05-11 HJO Traditional This company
K142263 2016-04-15 HKY Traditional This company
K100439 2010-07-16 HJO Traditional This company

From the Company

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

Information published by Shanghai Mediworks Precision Instruments Co., Ltd.
Founded 2004
Main products Ophthalmic Surgical Microscope, Dental Surgical Microscope, Anterior Segment Analyzer, Optical Biometer, Slit Lamp Microscope
Export markets Over 100 countries

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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