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Shanghai Mediworks Precision Instruments Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances

Name: Shanghai Mediworks Precision Instruments Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Mediworks Precision Instruments Co., Ltd. is registered with the FDA (registration 3005755367) in Shanghai, China. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 11, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005755367
Address: No.7, MingPu Phase II, No.3279 SanLu Road, MinHang District, Shanghai, China, Shanghai, China, 201100
Owner or operator: Shanghai MediWorks Precision Instruments Co., Ltd. (10031036)
Roles: Contract manufacturer, Manufacturer
First device listed: December 11, 2009
Registered through: 2026
Brand names listed: Anterior segment analyzer Scansys TA517, Applanation Tonometers, Automatic Fundus Camera FC162, Corneal Topographer DEA520, Digital Camera Module Kit DM390,DS650, Hand-held Fundus Camera FC160 FC161, Instrument table, Ophthalmic RefractometerV100 V101 V102 and more

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	PUE	2	Manufacturer	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Contract manufacturer	accessdata.fda.gov
Camera, Ophthalmic, General-Use	PJZ	2	Manufacturer	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Lens, Condensing, Diagnostic	HJL	1	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Manufacturer	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Manufacturer	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Manufacturer	accessdata.fda.gov
Table, Instrument, Powered, Ophthalmic	HRJ	1	Manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Manufacturer	accessdata.fda.gov
Topographer, Corneal, Ac-Powered	MMQ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 11, 2016	K152429	Slit Lamp Microscope	HJO	Substantially Equivalent	Shanghai Mediworks Precision Instruments Co. , Ltd.	accessdata.fda.gov
April 15, 2016	K142263	Applanation Tonometer	HKY	Substantially Equivalent	Shanghai Mediworks Precision Instruments Co. , Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 11, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.