EU Manufacturer
๐จ๐ณ China
Active
Hunan Kangxin Biotechnology Co., Ltd.
SRN: CN-MF-000020121
ยท
Room 301, 3rd Floor, Warehouse 5#, Block 6#, Xiangtan Comprehensive Free Trade Zone, 46#, Free Trade Road, Peace Street, Xiangtan Economic Development Zone 46#, 411215 Xiangtan, China
Basic UDI-DIs
73
Total Devices
74
On Market
74
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Room 301, 3rd Floor, Warehouse 5#, Block 6#, Xiangtan Comprehensive Free Trade Zone, 46#, Free Trade Road, Peace Street, Xiangtan Economic Development Zone 46#, 411215 Xiangtan, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
71
Eu Ivdr
2
Classification
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Eu Ivd General
71
Eu Ivd Class A
2
Device Types
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Certificate Health
No certificates registered for this manufacturer.
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 | ||||
|---|---|---|---|---|
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| ALPHAFETOPROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-CYCLIC CITRULLINATED PEPTIDE | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-MรLLERIAN HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) | EU IVDD | Eu Ivd General | On Market | 0 |
| BETA2-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) | EU IVDD | Eu Ivd General | On Market | 0 |
| C-PEPTIDE | EU IVDD | Eu Ivd General | On Market | 0 |
| C-REACTIVE PROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |
| CALPROTECTIN | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 125 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 19-9 | EU IVDD | Eu Ivd General | On Market | 0 |
| CARCINOEMBRYONIC ANTIGEN | EU IVDD | Eu Ivd General | On Market | 0 |
| CARDIAC MARKERS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| CARDIAC MARKERS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| CARDIAC MARKERS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATINE KINASE - MB MASS (IC) | EU IVDD | Eu Ivd General | On Market | 0 |
| CYFRA 21-1 | EU IVDD | Eu Ivd General | On Market | 0 |
| D-DIMER | 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 |
| ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| ESTRADIOL | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD (IC) | EU IVDD | Eu Ivd General | On Market | 0 |
| FERRITIN | EU IVDD | Eu Ivd General | On Market | 0 |
| FIBRONECTIN | EU IVDD | Eu Ivd General | On Market | 0 |
| FOLATE | EU IVDD | Eu Ivd General | On Market | 0 |
| FOLLICLE STIMULATING HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| FREE THYROXINE | EU IVDD | Eu Ivd General | On Market | 0 |
| FREE TRIIODOTHYRONINE | EU IVDD | Eu Ivd General | On Market | 0 |
| GASTRIN | EU IVDD | Eu Ivd General | On Market | 0 |
| GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI ANTIBODY ASSAYS | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI ANTIGEN DETECTION | EU IVDD | Eu Ivd General | On Market | 0 |
| HOMOCYSTEINE | EU IVDD | Eu Ivd General | On Market | 0 |
| HUMAN GROWTH HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOGLOBULIN E - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] | EU IVDD | Eu Ivd General | On Market | 0 |
| INSULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1 | EU IVDD | Eu Ivd General | On Market | 0 |
| INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 | EU IVDD | Eu Ivd General | On Market | 0 |
| INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C) | EU IVDD | Eu Ivd General | On Market | 0 |
| INTERLEUKIN 6 (IL-6) | EU IVDD | Eu Ivd General | On Market | 0 |
| IVD INSTRUMENTS - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| IVD INSTRUMENTS - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| IVD INSTRUMENTS - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| LUTEINISING HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |