Shanghai Mediworks Precision Instruments Co L T D

FDA Filings

This page includes the latest FDA filings for Shanghai Mediworks Precision Instruments Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005755367
• FEI Number: 3005755367
• Name: Mark Newkirk
• Owner & Operator: Shanghai MediWorks Precision Instruments Co., Ltd.
• Contact Address: No.7, MingPu Phase II, No.3279 SanLu Road, MinHang District, Shanghai,; Shanghai CN-31 Shanghai 201100 CN
• Official Correspondent:
  • weida Zhan
  • 86-021-54260423-x
• US Agent:
  • Mark Newkirk
  • EYEFFICIENT LLC
  • 330 9983786
  • 880 4178136
  • markn@eyefficient.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 865 BRANDON CIR Aurora, Ohio, 44202, UNITED STATES ; Aurora, OH 44202 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06945087500064 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2022-11-11
GUDID 06945087515013 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087512135 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087512128 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087512111 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087500217 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2022-11-10
GUDID 06945087500088 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087500071 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2022-11-10
GUDID 06945087500057 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2022-11-10
GUDID 06945087500040 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2022-11-10
GUDID 06945087500026 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087500002 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2022-11-10
GUDID 06945087580011 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-27
GUDID 06945087580004 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-27
GUDID 06945087516201 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-26
GUDID 06945087590027 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-25
GUDID 06945087590010 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-25
GUDID 06945087590003 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-25
GUDID 06945087525012 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-25
GUDID 06945087525005 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-25
GUDID 06945087520000 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-25
GUDID 06945087545027 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087545010 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087540022 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087540015 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087535073 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087535066 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087530023 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-18
GUDID 06945087530016 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2021-05-17
GUDID 06945087590119 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2020-10-28
GUDID 06945087516102 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2020-04-16
GUDID 06945087505175 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2020-03-20
GUDID 06945087561010 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	Mediworks	2019-09-23
MMQ Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Anterior Segment Analyzer	2019-04-21
GUDID 06945087510018 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2019-04-12
GUDID 06945087562017 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-23
GUDID 06945087539026 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087539019 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087536025 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087536018 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087535035 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087535028 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087535011 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087528037 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087528020 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087528013 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087526026 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087526019 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087517024 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087517017 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
GUDID 06945087516010 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.	MediWorks	2018-07-06
PUE Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Portable Slit Lamps	2017-11-28
PJZ Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Hand-held Fundus Camera	2016-10-24
HKN Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2016-09-06
PMN K152429 | HJO Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Slit Lamp	2016-05-12
PMN K152429 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD.	Slit Lamp Microscope	2016-05-11
PMN K142263 | HKY Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Applanation tonometer	2016-04-19
PMN K142263 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.	Applanation Tonometer	2016-04-15
HRM Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Surgical Microscope	2015-06-15
HPA Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HOS Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HMH Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HMF Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HMD Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HLM Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HLH Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HKW Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HKQ Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HKO Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Vision Screener	2013-11-14
HJG Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HJB Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-11-14
HRJ Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Mediworks	2013-10-31
PMN K100439 | HJO Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Slit Lamp	2010-07-19
PMN K100439 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.	MEDIWORKS SLIT LAMP	2010-07-16
HOX Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Vision Charts	2009-12-11
HJL Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]	Retina Lens	2009-12-11