康生保生物- 发展历程

1. 2001年深圳康生保生物技术有限公司成立

Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd. was established in 2001.

2. 2003年成功完成日本GC公司龋齿唾液检测产品的技术转接和生产

Successfully completed the technical transfer and production of caries saliva detection products

for GC Company from Japan in 2003.

3. 2004年获得体外诊断试剂认证范围的《药品GMP证书》

Obtained the "Pharmaceutical GMP Certificate" within the scope of in vitro diagnostic reagent in 2004.

4. 2006年搬迁至深圳福永新洁净厂房

Move to the new clean workshop in Fuyong, Shenzhen in 2006.

5. 2007年首次通过德国认证机构TÜV SÜD的EN ISO 13485:2003的质量体系认证。

In 2007, successfully received the EN ISO 13485:2003 certificate of quality management system issued by TÜV SÜD.

6. 2009年成功完成第一阶段瑞典ED公司9个酶联自身免疫产品的技术转接和生产。

Successfully completed the technical transfer and production of the first stage of 9 enzyme-linked autoimmunity tests (ELISA) for ED company from Sweden in 2009.

7. 2010年，流感A、流感B、HP、NeoPT 4个产品CE注册成功。成功完成第二阶段瑞典ED公司、伯乐公司8个酶联自身免疫产品的技术转接和生产。

Influenza A, Influenza B, HP and NeoPT products successfully received CE mark. Successfully completed the technical transfer and production of second stage of 8 enzyme-linked autoimmunity tests (ELISA) for ED company.

8. 2012年，PSA和FPSA 产品（list B）获得公告机构TÜV SÜD颁发的产品CE认证证书。

List B product (PSA and FPSA) received the CE certificate issued by Notified Body TÜV SÜD.

9. 2018年从深圳福永厂房搬迁至深圳福海新洁净厂房，并通过《医疗器械生产许可证》的地址变更审核。

Moved to the new clean workshop in Fuhai,Shenzhen, and passed the audit for address change under the Medical Device Production License in 2018.

10. 2019年成功获得EN ISO 13485：2016新法规质量体系认证证书。

In 2019, successfully received the EN ISO 13485:2016 certificate of quality management system issued by TÜV SÜD.

11. 2023年获得12个荧光免疫层析法试剂产品及1个配套检测仪器荧光免疫层析分析仪（FIA-T6）的注册证书。

Successfully received 13 certificates of fluorescence immunoassay reagents and the reader (FIA-T6) issued by Guangdong Medical Products Administration.