EU Manufacturer
🇨🇳 China
Active
Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
SRN: CN-MF-000024153
·
Second Floor, Block 3, An Da Electronic Industrial Park, Fu Hai, Bao An District, 518103 Shenzhen, China
Basic UDI-DIs
5
Total Devices
5
On Market
4
Off Market
1
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Second Floor, Block 3, An Da Electronic Industrial Park, Fu Hai, Bao An District, 518103 Shenzhen, China
- [email protected]
- Website
- www.ksbbiotech.com
Regulatory Overview
Regulation
Loading...
Eu Ivdd
4
Eu Ivdr
1
Classification
Loading...
Eu Ivd Annex 2 List B
4
Eu Ivd Class A
1
Device Types
Loading...
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 061788 0008 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | No. V1 061788 0008 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CancerCheck ® fPSA | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CancerCheck® PSA | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Colloidal Gold Reader | EU IVDR | Eu Ivd Class A | Not EU | 0 |
| PSA Rapid Test | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| fPSA Rapid Test | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |