Since its foundation in 1998, Stratek Co., Ltd. maintains a strong trust relationship with customers
We are growing year by year as a communication manufacturing company with expert parts.
Stratech is making the world happier and more convenient through continuous research and development and quality improvement.
2019
February The Notify body company (LL-C) Initial audit (ISO13485:2016)
July Changed address registered of medical device sales business (No. 2010-3830076-00024)
November Anyang-si Excellent Company selected (2019.11.01~2022.10.31)
2018
January INNO BIZ affirmation (2018.09.05~2021.09.05)
August Enterprise R&D Lab. approval
September Food & Drug Administration Medical Instrument Quality control standard product item add audit (GMP) (2017.11.22~2020.11.21)
2017
January Medical device manufacturing item certification (MDITAC, NO. 17-4004, Low-frequency stimulation [STIMFES, STF-3300, STF-5500])
January Medical device manufacturing item certification (MDITAC, NO. 17-4009, Functional Electrical Stimulation [FES-3000, FES-5000])
January Medical device manufacturing item approval (KFDA, NO. 17-23, Laser, therapeutic Medical laser apparatus + Electromagnetic therapy stimulator [MAGNASER, G-500])
March Medical device manufacturing item certification (MDITAC, NO. 17-4146, Medical vibrator [NovaTech, STS-1000])
April Medical device manufacturing item certification (MDITAC, No. 17-4248, Low-frequency stimulation)(LEOMEDII(STT-570))
April Medical device manufacturing item certification (MDITAC, No. 17-4245, Low-frequency stimulation)(LEOMEDIII(STT-200))
April Medical device manufacturing item certification (MDITAC, No.17-4209, Interferential Current Therapy)(PROMED7(STI-5000))
May The Notify body company (Kiwa) Audit (ISO13485: 2012)(2015.11.26~2018.11.26)
May CE Marking audit (Continuous Passive Motion (CPS-2000), Therapy Laser(STL-101)
November Venture business affirmation (2017.11.10~2019.11.09)
November Food & Drug Administration Medical Instrument Quality control standard fitness renewal (GMP) (2017.11.22~2020.11.21)
2016
May The Notify body company (Kiwa & CERMET) ex post Audit (ISO13485: 2012)(2014.10.06~2017.10.05)
May CE Marking (Continuous Passive Motion (CPS-2000), Digital Therapy Laser (STL-101)
June Factory space expansion Inspection completion
2015
January Medical device manufacturing item approval (KFDA, NO. 15-139, Interferential Current Therapy [STI-1301])
January Venture business affirmation (2015.01.04~2017.01.03)
May Certification company (Kiwa & CERMET) audit (ISO13485: 2003) (2014.10.06~2017.10.05)
May Medical device manufacturing item approval (KFDA, NO. 15-817, CO2 surgical laser [Hanimaehwa laser, COSCAN III ])
June Medical device manufacturing item approval (KFDA, NO. 15-939, Clinical Goniometer, powered
[Body Monitoring & Analysis System, BMS-1000])
September INNO BIZ affirmation (2015.09.04~2018.09.03)
November CE approval (Continuous Passive Motion (CPS-2000)/Digital Therapy laser (STL-101))
December Export promising small medium company designation (Gyeonggi Regional Small Medium Business Administration)
(2015.12.01~2017.11.30)
December Medical device manufacturing item certification (MDITAC, NO. 15-4424, Low-frequency stimulation [STIMFES,STF-3000])
2014
February Medical device manufacturing item approval (KFDA, No. 14-388, Acupuncture (STN-330))
May Certification company changed to Kiwa & CERMET (ISO13485: 2003) (2014.10.06~2017.10.05)
September Food & Drug Administration Medical Instrument Quality control standard fitness renewal (GMP)
(2014.11.22~2017.11.21)
November IBK Creation business selection (2014.11.21)
November Design patent (3D-Centour) (Registration no. 30-0773851) (14.11.27)
2013
January Venture company reaffirmations (2013.01.04~2015.01.03)
January Medical device manufacturing item registration (KFDA, NO. 13-43, Spinal stabilization exercise system [3D-Centour])
February Medical device manufacturing item approval (KFDA, No. 11-304, Sphygmograph + electrocardiograph (STD-1500))
October Medical device manufacturing item approval (KFDA, No. 09-110, Ultrasound therapy take-grant model (ST-30A))
October Medical device manufacturing item approval (KFDA, No. 08-217, Low frequency stimulator take-grant model (STT-150))
2012
January CE Marking renewal (Continuous Passive Motion (CPS-2000),
Co2 surgical laser system (STL-3000, STL-3000U, COSCAN-5000),
Diode surgical laser system (STL-275)) (2012.01.31~2017.01.31)
April ISO renewal (ISO13485: 2003) (2012.04.24~2015.04.05)
September INNO BIZ reaffirmation (2012.09.04~2015.09.03)
2011
January Venture business affirmation 2011.01.04~2013.01.03)
January CE Marking approval (Surgical Diode Laser System STL-275) (No. 2006-OSL-MDD-0152 1.0)
January CE Marking approval (Continuous Passive Motion Leg Exerciser CPS-2000)(No. 2006-OSL-MDD-0153 1.0)
June Industry-University Collaboration agreement (Anyang Science University)
November Food & Drug Administration Medical Instrument Quality control standard fitness renewal (GMP) (2011.11.22~2014.11.21)
2010
January Medical device manufacturing item approval(KFDA, No.10-003, Continuous Passive Motion Leg Exerciser CPS-2000)
April Medical device manufacturing item approval (KFDA, No. 10-393, Low-frequency Stimulator STT-550)
April Patent: HRV Interpolation regarding to heartbeat data by Doppler radar (No. 10-0956647)
July Medical equipment industry registration (No. 2010-3830076-00024)
July Medical equipment repair registration (No.-87)(Natural sciences treatment equipment, physical therapy,
bio-condition measurement instrument, cardiovascular fandangle, laser treatment)
September Medical device manufacturing item approval modification (KFDA, No.03-1083, Digital Non-invasive laser STL-301)
November Medical device manufacturing item approval (KFDA, No. 10-581, Surgical laser costa (STL-3000PD))
November Medical device manufacturing item approval (KFDA, No. 10-582, Surgical Laser costa (STL-3000P))