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Emdyca

Manufacturer

Boditech

South KoreaLegal entities : Boditech Med Inc.

First countries of placing on the market declared in EUDAMED : Austria, Czechia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

EU representative : Obelis s.a. (Belgium)

Website marketing@boditech.co.kr

36 categories, 97 models including 97 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Immunochemistry readers W0201020201
12 others
 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - hardware accessories W0201020180
3 others
 A IVDR EUDAMED record Report an error
Blood collection, capillary tubes W0501010203
3 others
 A IVDR EUDAMED record Report an error
Other virology controls - inf.imm. W0105080804
2 others
 – 98/79 EUDAMED record Report an error
Dengue virus W0105040611
1 other
 B IVDR, 98/79 EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
Coronavirus ag W0105041101 – 98/79 EUDAMED record Report an error
Influenza & para influenza W0105040604 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 B IVDR, 98/79 EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 C IVDR, 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) W0105040605 – 98/79 EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801 C IVDR, 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Haematology controls - RT & POC W0103010606 B IVDR EUDAMED record Report an error
Haemostasis controls - other W0103020799 – 98/79 EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399 – 98/79 EUDAMED record Report an error
Streptococcal direct antigen detection W0105011101 – 98/79 EUDAMED record Report an error
Adenovirus W0105040601 – 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101 A IVDR EUDAMED record Report an error
Bacteriology standards and calibrators - inf.imm. W0105080901 – 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 - low routine (with ise mode test/h <= 400) W0201010105 A IVDR EUDAMED record Report an error
Chikungunya virus W0105040625 – 98/79 EUDAMED record Report an error
Faeces collection devices W05019001 A IVDR EUDAMED record Report an error
Haematology standards and calibrators - RT & POC W0103010607 B IVDR EUDAMED record Report an error
Heating mantles W02079008 A IVDR EUDAMED record Report an error
Multiconstituent controls - inf.imm. W0105080807 – 98/79 EUDAMED record Report an error
Multiple infectious - multiplex assays - other W0105070599 – 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 – 98/79 EUDAMED record Report an error
Mycoplasma antigen detection W0105010801 – 98/79 EUDAMED record Report an error
Norovirus W0105040616 B IVDR, 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other W02050199 A IVDR EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - hardware accessories W02020680 B IVDR EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Urine strip readers W020101020101 A IVDR EUDAMED record Report an error
Virology reagents - other W01050499 – 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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