EU Manufacturer
🇨🇳 China
Active
Wuhan J.H. Bio-Tech Co., Ltd.
SRN: CN-MF-000019359
·
Accelerator Phase II, Biomedical Industrial Park, Biological Industry Base A86-1,A86-2, 430203 Hubei, China
Basic UDI-DIs
7
Total Devices
7
On Market
7
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Accelerator Phase II, Biomedical Industrial Park, Biological Industry Base A86-1,A86-2, 430203 Hubei, China
- [email protected]
- Phone
- +86-13237177338
Regulatory Overview
Regulation
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Eu Ivdd
7
Classification
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Eu Ivd General
4
Eu Ivd Self Testing
3
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Expired / Withdrawn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 IV (excluding sections 4, 6) | HL2409548-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2409548-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇫🇷 France
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| LH - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| LH - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| LH - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| LH - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| One Step HCG Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step HCG Pregnancy Test (Colloidal Gold) | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step Ovulation Test (Colloidal Gold) | EU IVDD | Eu Ivd Self Testing | On Market | 1 |