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Emdyca

Manufacturer

Anhui Deepblue Medical Technology

ChinaLegal entities : ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Markets : Croatia · Finland · Germany · Italy · Poland · Spain · United States

Approvals : EU – class I, B, C · United States (FDA) – 510(k) : 2 · class I, II · latest in 2024 · see on the FDA website

EU representative : Luxus Lebenswelt GmbH (Germany)

sales@dbluemedical.com

34 categories, 88 models including 88 on the market, 1 country

Export to CSV
CategoryEMDN codeRegistered modelsClassContact
H. pylori antigen detection W0105010401
8 others
 – 98/79 EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399
6 others
 C IVDR, 98/79 EUDAMED record Report an error
Virology - RT & POC - other W0105099099
3 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007
2 others
 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402
2 others
 – 98/79 EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 C IVDR, 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401 – 98/79 EUDAMED record Report an error
Strep. a - RT & POC W0105090103 C IVDR, 98/79 EUDAMED record Report an error
Chlamydia pneumoniae antibody assays total W0105010113 – 98/79 EUDAMED record Report an error
Mycobacterial antibody assays W0105010702 – 98/79 EUDAMED record Report an error
Salmonella reagents - other W0105011099 – 98/79 EUDAMED record Report an error
Toxoplasma antibody (total) W0105050101 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699 – 98/79 EUDAMED record Report an error
Adenovirus - NA reagents W0105040501 – 98/79 EUDAMED record Report an error
Avian influenza W0105040615 – 98/79 EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699 – 98/79 EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents W0105070202 – 98/79 EUDAMED record Report an error
Chikungunya virus W0105040625 – 98/79 EUDAMED record Report an error
Gonococcal detection by NA reagents W0105010203 – 98/79 EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents W0105070201 – 98/79 EUDAMED record Report an error
H. pylori - RT & POC W0105090102 C IVDR EUDAMED record Report an error
Human metapneumovirus - NA reagents W0105040517 – 98/79 EUDAMED record Report an error
Infectious immunology - other W0105900299 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Multiple viruses - other W01050799 – 98/79 EUDAMED record Report an error
Mycoplasma antigen detection W0105010801 – 98/79 EUDAMED record Report an error
Norovirus W0105040616 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) W0105040605 – 98/79 EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Salmonella antigen detection W0105011001 – 98/79 EUDAMED record Report an error
Syphilis antibody assays total W0105010302 – 98/79 EUDAMED record Report an error
Ultrasound scanners - consumables Z11040185 I MDR EUDAMED record Report an error
Zika virus W0105040630 – 98/79 EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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