EU Manufacturer
๐จ๐ณ China
Active
Shanghai BioGerm Medical Technology Co., Ltd.
SRN: CN-MF-000018164
ยท
Building 3, No. 1588 Huhang Road, Fengxian District, 201401 Shanghai, PEOPLE'S REPUBLIC OF CHINA, 201401 Shanghai, China
Basic UDI-DIs
9
Total Devices
9
On Market
9
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Building 3, No. 1588 Huhang Road, Fengxian District, 201401 Shanghai, PEOPLE'S REPUBLIC OF CHINA, 201401 Shanghai, China
- [email protected]
- Phone
- +86 13651628568
Regulatory Overview
Regulation
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Eu Ivdd
6
Eu Ivdr
3
Classification
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Eu Ivd Class A
3
Eu Ivd General
3
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Expired / Withdrawn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-076/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Automatic Nucleic Acid Purification Instrument | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BioGerm SARS-CoV-2 Antigen Self Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BioGerm SARS-CoV-2 Antigen Self Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BioGerm SARS-CoV-2 Antigen Self Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | EU IVDD | Eu Ivd General | On Market | 0 |
| Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | EU IVDD | Eu Ivd General | On Market | 0 |
| Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA) | EU IVDD | Eu Ivd General | On Market | 0 |
| Nucleic acid extraction and purification kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Nucleic acid extraction and purification kit | EU IVDR | Eu Ivd Class A | On Market | 0 |