EU Manufacturer
๐จ๐ณ China
Active
New Gene (Hangzhou) Bioengineering Co., Ltd.
SRN: CN-MF-000013826
ยท
688 Bin'an Road, Changhe Street 688, 310051 Hangzhou City, China
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
14
Basic Information
- Address
- 688 Bin'an Road, Changhe Street 688, 310051 Hangzhou City, China
- [email protected]
- Website
- https://www.new-gene.net/
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
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-476/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 14 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |