Skip to content
Emdyca

Manufacturer

Bgi

DenmarkLegal entities : BGI EUROPE A/S

Markets : Denmark

Approvals : EU – class A

Website

22 categories, 43 models including 43 on the market, 1 country

Export to CSV
CategoryEMDN codeRegistered modelsClassContact
D-dimer - RT & POC W0103020803 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401 – 98/79 EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - medical device software Z129092 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - IVD medical device software W02050192 – 98/79 EUDAMED record Report an error
Samples collection devices - other W05019099 A IVDR EUDAMED record Report an error
Faeces collection devices W05019001 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - software accessories W02050182 – 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus W0105900102 A IVDR, 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101 A IVDR EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A IVDR EUDAMED record Report an error
Adenovirus - NA reagents W0105040501 – 98/79 EUDAMED record Report an error
Blood collection, tubes with additives or serum separator W050101010201 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800) W0201010102 A IVDR EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 – 98/79 EUDAMED record Report an error
High performance liquid chromatography systems - other W0201050299 A IVDR EUDAMED record Report an error
IVD general use consumable devices - other W0599 A IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents W0105040505 – 98/79 EUDAMED record Report an error
Various general purpose IVD instruments - other W02079099 A IVDR EUDAMED record Report an error
Various sample processing instruments - other W02069099 A IVDR 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.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.