Mark Newkirk

FDA Filings

This page includes the latest FDA filings for Mark Newkirk. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005755367
FEI Number3005755367
NameMark Newkirk
Owner & OperatorShanghai MediWorks Precision Instruments Co., Ltd.
Contact AddressNo.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
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address865 BRANDON CIR Aurora, Ohio, 44202, UNITED STATES
Aurora, OH 44202 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

Registration Number3015168040
FEI Number3015168040
NameMark Newkirk
Owner & OperatorShanghai VisuScience Meditech Co., Ltd.
Contact AddressNo. 344 Sanlin Road
Shanghai CN-31 Shanghai 200124 CN
Official Correspondent
  • Aaron Hong
  • 86-213-4973659-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address865 Brandon Cir
Aurora, OH 44202 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Respirator, Mask2020-03-25
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
VisuScience2020-01-05
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Portable Slit Lamp2020-01-05
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Handheld Slit Lamp SL1911E2020-01-05
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
OPHTHALMOSCOPE2020-01-05
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
VisuScience Streak Retinoscopes2020-01-05
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
iRelief Eye Mask, Thermalon2019-08-15
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Anterior Segment Analyzer2019-04-21
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MD-2300S Ultrasonic A/B Scanner for Ophthalmology2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MD-2300S Ultrasonic A/B Scanner for Ophthalmology2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Applanation Tonometers2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MD-1000A Ultrasonic Biomneter for Ophthalmology, MD-1000P Ultrasonic Biometer for Ophthalmology, MD-1000A/P Ultrasonic2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MD-1000A Ultrasonic Biomneter for Ophthalmology, MD-1000P Ultrasonic Biometer for Ophthalmology, MD-1000A/P Ultrasonic2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MD-6000 Bladder Scanner2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MD-6000 Bladder Scanner2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
ODM-2100, ODM-2200 Ultrasonic N/B Scanner for Ophthalmology2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
ODM-2100, ODM-2200 Ultrasonic N/B Scanner for Ophthalmology2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Camera Fundus2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
QuikVue Smartphones Eye Imaging Adaptor VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Ophthalmic Image Viewer App VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Corneal Topographer2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Washer-disinfector VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Surgical Camera2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC,SM-1000L,SM-2000L, SM-2000J2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Table, instrument, powered, ophthalmic,VT-20, VT-36, VT-36C, VT-430, VT-10002019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Confirmation Test2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Perimeter IVS201A, IVS201B, IFA900, IFA950, IFA960 VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Trial Lens Set VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Trial Clip VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Frame, Trial, Ophthalmic, VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Occluder2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Eye Mask2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Chart, visual acuity VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Projector2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Ophthalmic2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Crossed Cylinder, VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
RACK, SKIASCOPIC2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Opthalmic Unit VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Ophthalmic chair VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Stool, Chair, VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Lens Clock; Radian Aparatus2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Focimeter2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Auto/Manual Lensmeter, L900, L8002019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Indirect Ophthalmoscope VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Pupillometer, PD ruler, VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
PD Meter VIsuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Ophthalmic Prism Bar VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Maddox Lens, VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Ophthalmic Prism Rotary VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Refractometer, ophthalmic, ARK7800A, ARK7800B, ARK7600, AR7600, ARK7610, AR7610 VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Digital Refractor, Vision Tester, Phoropter, VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Retinoscope VisuScience2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
Diopter lens; Retina Lens; Aspheric lens; Bio Lens; Slit Lamp Lens; Non-contact Surgical Lens; Retinal Scale;2019-02-03
Mark Newkirk [Shanghai VisuScience Meditech Co., Ltd.]
LOUPE, BINOCULAR, LOW POWER2019-02-03
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Portable Slit Lamps2017-11-28
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Hand-held Fundus Camera2016-10-24
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2016-09-06
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Slit Lamp2016-05-12
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Applanation tonometer2016-04-19
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Surgical Microscope2015-06-15
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Vision Screener2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-11-14
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Mediworks2013-10-31
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Slit Lamp2010-07-19
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Vision Charts2009-12-11
Mark Newkirk [Shanghai MediWorks Precision Instruments Co., Ltd.]
Retina Lens2009-12-11

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018041747872Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland2008 HONDA ODYSSEY VIN: 5FNRL38758B0652461 PCS
2018041031703Anvers,Belgium -> Houston, TexasHOUSEHOLD GOODS AND PERSONAL E FFECTS HS CODE: 9805.00.50 FREIGHT PREPAID UNDER TERMS OF SERVICE CONTRACT CONTRACT #: SC17NE4 CTN
2018041031706Anvers,Belgium -> Houston, TexasHOUSEHOLD GOODS AND PERSONAL E FFECTS HS CODE: 9805.00.50 FREIGHT PREPAID UNDER TERMS OF SERVICE CONTRACT CONTRACT #: SC17NE10 CTN
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