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Sign in to claim this brandShenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
China·CN-MF-000024153
Last updated June 8, 2026
About
Shenzhen Kangshengbao Biotechnology Co., Ltd. is a high-tech enterprise specializing in the research, development, manufacturing, and commercialization of in vitro diagnostic (IVD) products. With a strong foundation in advanced diagnostic technologies and a robust quality management system, the company is committed to delivering reliable, high-performance products to global markets. Guided by a customer-centric approach, we strive to maintain the highest standards in quality, regulatory compliance, and service excellence.
From the manufacturer's own website. Source
Information
- Country
- China
- Address
- Second Floor, Block 3, An Da Electronic Industrial Park, Fu Hai, Bao An District, Shenzhen, China
- Website
- www.ksbbiotech.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- ChunHui Liang
- EUDAMED SRN
- CN-MF-000024153
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (90)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cTnI/DD/BNP Rapid Detect | 808171 | EUDAMED | IVD General | Active |
| MYO Rapid Detect | 808168 | EUDAMED | IVD General | Active |
| InfectCheck CRP | K12-CRP | EUDAMED | IVD General | Active |
| BodyCheck Ferritin | 811025/K52-FER | EUDAMED | IVD General | Active |
| CancerCheck® PSA | K32-PSA | EUDAMED | IVD Annex II List B | Active |
| Colloidal Gold Reader | GIA100 | EUDAMED | Class A | Active |
| Total T4 Rapid Detect | 808176 | EUDAMED | IVD General | Active |
| 25-OH VD Rapid Detect | 808173 | EUDAMED | IVD General | Active |
| PRL Rapid Detect | 808183 | EUDAMED | IVD General | Active |
| LH Rapid Detect | 808181 | EUDAMED | IVD General | Active |
| AMH Rapid Detect | 808179 | EUDAMED | IVD General | Active |
| CancerCheck ® fPSA | K32-FPSA | EUDAMED | IVD Annex II List B | Active |
| Adenovirus Rapid Test | 808126-1 | EUDAMED | IVD General | Active |
| 25-OH Vitamin D Rapid Test | 808174 | EUDAMED | IVD General | Active |
| RSV Rapid Test | 808121-1 | EUDAMED | IVD General | Active |
| CA19-9 Rapid Test | 808086-1 | EUDAMED | IVD General | Active |
| PROG Rapid Detect | 808182 | EUDAMED | IVD General | Active |
| D-Dimer Rapid Detect | 808167 | EUDAMED | IVD General | Active |
| Strep A Rapid Test | 808087-1 | EUDAMED | IVD General | Active |
| PRL Rapid Test | 811021 | EUDAMED | IVD General | Active |
| CA15-3 Rapid Test | 808085-1 | EUDAMED | IVD General | Active |
| PSA Rapid Test | 811002 | EUDAMED | IVD Annex II List B | Active |
| CrinoCheck SHBG | 811023/K42-SHBG | EUDAMED | IVD General | Active |
| Free T4 Rapid Detect | 808178 | EUDAMED | IVD General | Active |
| cTnI/MYO/CK-MB Rapid Detect | 808165 | EUDAMED | IVD General | Active |
| Flu B Rapid Test | 808050 | EUDAMED | IVD General | Active |
| CrinoCheck TSH | K42-TSH | EUDAMED | IVD General | Active |
| Flu A & Flu B Rapid Test | 808051 | EUDAMED | IVD General | Active |
| H-FABP Rapid Test | 808039 | EUDAMED | IVD General | Active |
| PCT/IL-6 Rapid Detect | 808163 | EUDAMED | IVD General | Active |
| Testosterone Rapid Test | 808109 | EUDAMED | IVD General | Active |
| AMH Rapid Test | 811022 | EUDAMED | IVD General | Active |
| InfectCheck SARS-CoV-2/RSV/FluA/FluB | 811028/ K12-RVPanel4 | EUDAMED | IVD General | Active |
| CEA Rapid Test | 808073-1 | EUDAMED | IVD General | Active |
| TSH Rapid Detect | 808186 | EUDAMED | IVD General | Active |
| LH Rapid Test | 808127 | EUDAMED | IVD General | Active |
| BNP Rapid Detect | 808170 | EUDAMED | IVD General | Active |
| PCT Rapid Detect | 808158 | EUDAMED | IVD General | Active |
| CrinoCheck® LH-FSH | 808144 | EUDAMED | IVD General | Active |
| fPSA Rapid Test | 811003 | EUDAMED | IVD Annex II List B | Active |
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Authorised Representatives
- QbD RepS BV BE
Importers
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Notified Bodies
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Authorities
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