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Home›China›Shanghai Mediworks Precision Instruments Co. , Ltd.

Shanghai Mediworks Precision Instruments Co. , Ltd.

China · Shanghai
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
13listed device types
Class I 8Class II 5Class III 0
plus 13 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States13 registration records, 3 510(k), 0 PMA, 1 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia7 confirmed, 0 excluded
Manufacturer names merged into this page: SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. · SHANGHAI MEDIWORKS PRECISION INSTRUMENT CO LTD · Shanghai Mediworks Precision Instrument Co. · Shanghai MediWorks Precision Instruments Co., Ltd · Shanghai Mediworks Precision Instruments Co., Ltd.
Same-named companies — This database also contains companies with near-identical names: SHANGHAI MEDIWORKS PRECISION INSTRUMENT CO LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shanghai

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12010 · K100439
22016 · K152429

FDA listed device types

showing 8 of 13
Medical Device Data System 1Lens, Condensing, Diagnostic 1Chart, Visual Acuity 1Topographer, Corneal, Ac-Powered 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Refractometer, Ophthalmic 1Table, Instrument, Powered, Ophthalmic 1Microscope, Surgical, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK152429Slit Lamp Microscope2016-05-11
USK142263Applanation Tonometer2016-04-15
USK100439MEDIWORKS SLIT LAMP2010-07-16
SAME0000006799SFDAA00001Slitlamp Microscope—
SAME0000006767SFDAA00006Slit Lamp Microscope—

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