EU Manufacturer
๐จ๐ณ China
Active
Shenzhen AmTech Bioengineering Ltd., Inc.
SRN: CN-MF-000043067
ยท
Room 901&1001&1101, Building A1, Building A1A2, China Merchants Guangming Science Park, Guanguang Road, Fenghuang Community, Fenghuang Street,Guangming District, 518000 Shenzhen, China
Basic UDI-DIs
121
Total Devices
121
On Market
121
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Room 901&1001&1101, Building A1, Building A1A2, China Merchants Guangming Science Park, Guanguang Road, Fenghuang Community, Fenghuang Street,Guangming District, 518000 Shenzhen, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
120
Eu Ivdr
1
Classification
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Eu Ivd General
120
Eu Ivd Class A
1
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 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-ACID GLYCOPROTEIN (OROSOMUCOID) | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A2-MACROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A2-MACROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ADENOSINE DEAMINASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALANINE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALKALINE PHOSPHATASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| ALPHA-FUCOSIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALPHAFETOPROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |
| AMYLASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-CYCLIC CITRULLINATED PEPTIDE | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-CYCLIC CITRULLINATED PEPTIDE | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-STREPTOLYSIN O (QUANTITATIVE) | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-STREPTOLYSIN O (QUANTITATIVE) | EU IVDD | Eu Ivd General | On Market | 0 |
| APOLIPOPROTEIN A I | EU IVDD | Eu Ivd General | On Market | 0 |
| APOLIPOPROTEIN B | EU IVDD | Eu Ivd General | On Market | 0 |
| APOLIPOPROTEIN E SUB-TYPING | EU IVDD | Eu Ivd General | On Market | 0 |
| ASPARTATE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BETA2-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| BETA2-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| BICARBONATE | EU IVDD | Eu Ivd General | On Market | 0 |
| BILE ACIDS | EU IVDD | Eu Ivd General | On Market | 0 |
| BILIRUBIN | EU IVDD | Eu Ivd General | On Market | 0 |
| BILIRUBIN | EU IVDD | Eu Ivd General | On Market | 0 |
| C-REACTIVE PROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 125 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 15-3 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 19-9 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 242 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 50 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 72-4 | EU IVDD | Eu Ivd General | On Market | 0 |
| CARCINOEMBRYONIC ANTIGEN | EU IVDD | Eu Ivd General | On Market | 0 |
| CHOLESTEROL | EU IVDD | Eu Ivd General | On Market | 0 |
| CHOLINESTERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| CLINICAL CHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| COMPLEMENT COMPONENT C3/C3C | EU IVDD | Eu Ivd General | On Market | 0 |
| COMPLEMENT COMPONENT C4 | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATINE KINASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATINE KINASE ISOENZYMES | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATINE KINASE ISOENZYMES | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATININE | EU IVDD | Eu Ivd General | On Market | 0 |