EU Manufacturer
🇨🇳 China
Active
BioDetect（Xiamen）Biotechnology Co., Ltd.
SRN: CN-MF-000001098
·
Wengjiao West Road 2066, 361026 Xiamen, Fujian, China
Basic UDI-DIs
20
Total Devices
20
On Market
20
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Wengjiao West Road 2066, 361026 Xiamen, Fujian, China
- [email protected]
- Phone
- +86-592-6515720
- Website
- www.Biodetect.cn
Regulatory Overview
Regulation
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Eu Ivdd
20
Classification
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Eu Ivd General
17
Eu Ivd Self Testing
3
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Expired / Withdrawn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-038/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom