EU Manufacturer
🇨🇳 China
Active
Hangzhou Clongene Biotech Co., Ltd.
SRN: CN-MF-000030069
·
Yichuang Road No. 1, 311121 Hangzhou, China
Basic UDI-DIs
7
Total Devices
7
On Market
7
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
1
Watch Hangzhou Clongene Biotech Co., Ltd. for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- Yichuang Road No. 1, 311121 Hangzhou, China
- [email protected]
- Phone
- +86-571-88617879
- Website
- https://en.clongene.com
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
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
3
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2041176-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2041176-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-017/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇭🇺 Hungary
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| COVID-19 Antigen Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| COVID-19 Antigen Rapid Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Fecal Occult Blood Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| H.pylori Antigen Rapid Test Cassette (Feces) | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG Pregnancy Rapid Tests | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| LH Ovulation Rapid Tests | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Marijuana (THC) Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |