November: Founding of Safecare Biotech(Hangzhou)Co.,Ltd by a professional team
2013
February: Safecare obtained ISO13485 and ISO9001 certificate.
August: Obtains CE certificate for most of the rapid tests for professional use
2014
July: Safecare moved to a new factory which is located in the State Future Hi-tech Park with 1500㎡ non-dust GMP workshop.
November: Patent for Dry-type Biochemical test strips approved by State Intellectual Property Office of China.
2015
February: Patent for Urine Alcohol test strips approved by State Intellectual Property Office of China.
July: Announces formation of Safecare Biotech Co.Ltd– US
August: A contract signed with a UK distributor with an order of $200,000 and passed the European based on-site factory inspection audit .
2016
September: FDA 510K and CLIA Waived approval for urine drugs tests for THC,AMP &COC
October: Patent for Integrated Drug Screen Test Key Cup approved by State Intellectual Property Office of China.
November: Patent for Drugs Abuse Test System by State Intellectual Property Office of China.
December: Number of countries in which Safecare Biotech-manufactured products are distributed exceeds 60 for the first time.
2017
February:Named to the Inc. 5000 list of fastest-growing companies in China.
August: Enlarges the non-dust workshop up to 2500㎡ and the invests on automate assembling machines.
2018
July: Gets Approval of TUV HCG pregnancy self-testing CE certificate
August: Patent for urine specimen cup approved by State Intellectual Property Office of China.
September: FDA 510K and CLIA Waived approval for urine multi drugs tests for 8 parameters
2019
July: Safecare had 30 acres of our own place to build and expand our facility and factory.
2020
February: During the serious epidemic of nova coronavirus, COVID-19 IgG/IgM Rapid Test Kit(Colloidal Gold Method) was developed by our team with good feedbacks over the world.
March: Safecare COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold Method) was CE approved and could be marketed in EU market.
April: Safecare submitted FDA registration for our COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold Method) and got pre EUA for the tests.
July: Safecare COVID-19 IgG/IgM rapid test kit (Colloidal Gold Method) was used in many labs and clinics and hospitals with the accuracy 98.9%,which is a great milestone for the detection of infection of covid at serology test. Safecare will continue to do contributions to save human life.
August: Safecare early pregnancy test kit got FDA 510K approval and Clia Waived
2021
September：SAFECARE COVID-19 Antigen Rapid Test Kit(Swab) For Self-Testing was CE approved by Notified body PCBC
Safecare COVID-19 Antigen Rapid Test Kit(Swab) has successfully registered in Mongolia!
Safecare products passed the registration of South Africa
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