EU Manufacturer
🇨🇳 China
Active
Zhongshan Bio-Tech Co., Ltd.
SRN: CN-MF-000028828
·
Shengwugu Road, National Health Technology Park, Torch Hi-Tech Development Zone No.1 , 528437 Zhongshan, China
Basic UDI-DIs
24
Total Devices
24
On Market
24
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Shengwugu Road, National Health Technology Park, Torch Hi-Tech Development Zone No.1 , 528437 Zhongshan, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
24
Classification
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Eu Ivd General
20
Eu Ivd Self Testing
4
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/057/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-264/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ALPHAFETOPROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |
| CARCINOEMBRYONIC ANTIGEN | EU IVDD | Eu Ivd General | On Market | 0 |
| EBV ANTIBODIES - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| EBV ANTIBODIES - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| EBV ANTIBODIES - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| HANTAVIRUS / BUNYAVIRUS | EU IVDD | Eu Ivd General | On Market | 0 |
| HANTAVIRUS / BUNYAVIRUS | EU IVDD | Eu Ivd General | On Market | 0 |
| HANTAVIRUS / BUNYAVIRUS | EU IVDD | Eu Ivd General | On Market | 0 |
| HEV ANTIBODY IGM | EU IVDD | Eu Ivd General | On Market | 0 |
| HEV ANTIBODY IGM | EU IVDD | Eu Ivd General | On Market | 0 |
| INFLUENZA A AND /OR B - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| PLASMODIUM (MALARIA) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| PLASMODIUM (MALARIA) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| PLASMODIUM (MALARIA) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| PROCALCITONIN | EU IVDD | Eu Ivd General | On Market | 0 |
| SYPHILIS ANTIBODY ASSAYS TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |