EU Manufacturer
🇨🇳 China
Active
Helixgen (GUANGZHOU) Co., Ltd.
SRN: CN-MF-000034593
·
Unit 901,C2 No.182 Kexue Ave. Science Town Guangzhou Development District, 510663 Guangzhou,Guangdong, China
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Unit 901,C2 No.182 Kexue Ave. Science Town Guangzhou Development District, 510663 Guangzhou,Guangdong, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
2
Classification
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Eu Ivd Self Testing
2
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Expired / Withdrawn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) | V1 105461 0002 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | V1 105461 0002 | TÜV SÜD Product Service GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| PROTHROMBIN TIME RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| RAPID TEST HEMOSTASIS INSTRUMENTS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |