EU Manufacturer
🇨🇳 China
Active
Shenzhen Superbio Technology Co.,Ltd.
SRN: CN-MF-000024149
·
Building B, Xinzheng, 71 Area, Xin'an Sub-District, Bao'an, Shenzhen, 518101 Guangdong, P.R. China, 518101 Shenzhen, China
Basic UDI-DIs
589
Total Devices
591
On Market
591
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Building B, Xinzheng, 71 Area, Xin'an Sub-District, Bao'an, Shenzhen, 518101 Guangdong, P.R. China, 518101 Shenzhen, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
587
Eu Ivdr
2
Classification
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Eu Ivd General
584
Eu Ivd Self Testing
3
Eu Ivd Class A
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-254/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| S-Trust Multi-Drug Test Dip Card (Colloidal Gold) | EU IVDD | Eu Ivd General | On Market | 0 |
| S-Trust Multi-Drug Test Dip Card (Colloidal Gold) | EU IVDD | Eu Ivd General | On Market | 0 |
| S-Trust Multi-Drug Test Dip Card (Colloidal Gold) | EU IVDD | Eu Ivd General | On Market | 0 |
| S-Trust Multi-Drug Test Dip Card (Colloidal Gold) | EU IVDD | Eu Ivd General | On Market | 0 |
| S-Trust Multi-Drug Test Dip Card (Colloidal Gold) | EU IVDD | Eu Ivd General | On Market | 0 |
| S-Trust Multi-Drug Test Dip Card (Colloidal Gold) | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-Novel Coronavirus(2019-nCoV) IgG/IgM GICA Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| 2019-nCoV Antigen Saliva Rapid Test (Immunochromatography Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| 2019-nCoV Neutralizing Antibody Detection Kit (Fluorescence Immunochromatography) | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-OH-VD Assay Kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-OH-VD Assay Kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-OH-VD Control | EU IVDD | Eu Ivd General | On Market | 0 |
| AFP Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| AFP Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| AFP Control | EU IVDD | Eu Ivd General | On Market | 0 |
| AMH Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| AMH Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| AMH Control | EU IVDD | Eu Ivd General | On Market | 0 |
| Adenovims (ADV) Antigen Rapid Test (Fluorescence Immunochromatographic Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| Adenovims (ADV) Antigen Rapid Test (Immunochromatographic Assay) | EU IVDD | Eu Ivd General | On Market | 0 |
| Anti-TPO Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| Anti-TPO Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| Anti-Tg Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| Anti-Tg Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| Aβ1-42 Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| Aβ1-42 Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP Control | EU IVDD | Eu Ivd General | On Market | 0 |
| C-P Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| C-P Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| CEA Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| CEA Assay kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| CEA Control | EU IVDD | Eu Ivd General | On Market | 0 |
| CK-MB Assay Kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| CK-MB Assay Kit CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| CK-MB Control | EU IVDD | Eu Ivd General | On Market | 0 |
| CLIA AFP Calibrator | EU IVDD | Eu Ivd General | On Market | 0 |
| CLIA Aβ1-42 Calibrator | EU IVDD | Eu Ivd General | On Market | 0 |
| CLIA hs-cTnT Control | EU IVDD | Eu Ivd General | On Market | 0 |
| CLIA 25-OH-VD Calibrator | EU IVDD | Eu Ivd General | On Market | 0 |
| CLIA 25-OH-VD Control | EU IVDD | Eu Ivd General | On Market | 0 |