EU Manufacturer
๐จ๐ณ China
Active
Anbio (Xiamen) Biotechnology Co.,Ltd.
SRN: CN-MF-000023936
ยท
Xinyang Street No.2016, Wengjiao West Road, 361026 Xiamen,Fujian, China
Basic UDI-DIs
32
Total Devices
35
On Market
35
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
31
Basic Information
- Address
- Xinyang Street No.2016, Wengjiao West Road, 361026 Xiamen,Fujian, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
29
Eu Ivdr
3
Classification
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Eu Ivd General
24
Eu Ivd Self Testing
5
Eu Ivd Class A
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Expired / Withdrawn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-068/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 31 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
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ALANINE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| ALKALINE PHOSPHATASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| AMYLASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| ASPARTATE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| Anbio | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Anbio | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Anbio | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Anbio | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Anbio | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Anbio Biotech | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Anbio Biotech | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BILIRUBIN | EU IVDD | Eu Ivd General | On Market | 0 |
| BOIRON | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BOIRON | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BOIRON | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BOIRON | EU IVDD | Eu Ivd General | On Market | 0 |
| CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CHOLESTEROL TEST STRIPS | EU IVDD | Eu Ivd General | On Market | 0 |
| CHOLINESTERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATININE ANALYSIS TEST STRIPS | EU IVDD | Eu Ivd General | On Market | 0 |
| DENGUE VIRUS | EU IVDD | Eu Ivd General | On Market | 0 |
| DENGUE VIRUS | EU IVDD | Eu Ivd General | On Market | 0 |
| DENGUE VIRUS | EU IVDD | Eu Ivd General | On Market | 0 |
| ETHANOL (ALCOHOL) | EU IVDD | Eu Ivd General | On Market | 0 |
| GAMMA GLUTAMYLTRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd General | On Market | 0 |
| HIGH DENSITY LIPOPROTEIN CHOLESTEROL | EU IVDD | Eu Ivd General | On Market | 0 |
| HYDROXYBUTYRATE DEHYDROGENASE | EU IVDD | Eu Ivd General | On Market | 0 |
| LACTATE DEHYDROGENASE L ( LDH - L --> P ) | EU IVDD | Eu Ivd General | On Market | 0 |
| LIPASE | EU IVDD | Eu Ivd General | On Market | 0 |
| SUBSTRATES - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| TRIGLYCERIDES | EU IVDD | Eu Ivd General | On Market | 0 |
| UREA/BLOOD UREA NITROGEN | EU IVDD | Eu Ivd General | On Market | 0 |
| URIC ACID | EU IVDD | Eu Ivd General | On Market | 0 |