EU Manufacturer
🇨🇳 China
Active
HangZhou Biotest Biotech Co.,Ltd.
SRN: CN-MF-000008191
·
No. 17, Futai Road, Zhongtai Street, Yuhang District, 311121 Hangzhou, China
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- No. 17, Futai Road, Zhongtai Street, Yuhang District, 311121 Hangzhou, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
4
Classification
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Eu Ivd General
2
Eu Ivd Self Testing
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Expired / Withdrawn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 IV (excluding sections 4, 6) | V10774340015 | TÜV SÜD Product Service GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Ferrarihub | EU IVDD | Eu Ivd General | On Market | 0 |
| Rightsign | EU IVDD | Eu Ivd General | On Market | 0 |
| TRIGNOSTICS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| TRIGNOSTICS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |