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Emdyca

Manufacturer

Abbott

Costa Rica, Germany, Ireland, Italy, Japan, Netherlands, Norway, South Korea, United Kingdom (ex Northern Ireland), United StatesLegal entities : ABBOTT GmbH, ABBOTT S.r.l., Abbott Biologicals B.V.

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Türkiye

Public contracts won : France 794, Spain 271, Italy 156, Portugal 60, Czechia 26, Poland 17, Germany 13, Belgium 11, Netherlands 11, Greece 8, Austria 6, Denmark 2 and 3 more countries

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website EUDAMEDInq_EP@abbott.com

135 categories, 515 models including 513 on the market, 10 countries

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CategoryEMDN codeRegistered modelsClassContact
Virology - RT & POC - other W0105099099
112 others
 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401
22 others
 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - software accessories W02050182
18 others
 A IVDR EUDAMED record Report an error
Dengue virus W0105040611
12 others
 – 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007
8 others
 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004
8 others
 – 98/79 EUDAMED record Report an error
HIV 1 / 2 - RT & POC W0105090302
6 others
 – 98/79 EUDAMED record Report an error
Other virology controls - inf.imm. W0105080804
5 others
 – 98/79 EUDAMED record Report an error
Various instruments for cardiology and cardiac surgery - medical device software Z12059092
5 others
 IIb 93/42 EUDAMED record Report an error
Syphilis - RT & POC W0105090105
3 others
 – 98/79 EUDAMED record Report an error
Non invasive blood sugar monitoring systems Z1204011501
2 others
 IIa, IIb MDR EUDAMED record Report an error
Strep. a - RT & POC W0105090103
2 others
 – 98/79 EUDAMED record Report an error
Controls infectious immunology - RT & POC W0105094001
1 other
 – 98/79 EUDAMED record Report an error
Coronavirus igg W0105041103
1 other
 B IVDR, 98/79 EUDAMED record Report an error
Leptospira W0105011704
1 other
 – 98/79 EUDAMED record Report an error
Other virology standards and calibrators - inf.imm. W0105080904
1 other
 – 98/79 EUDAMED record Report an error
Parasites - RT & POC - other W0105090499
1 other
 – 98/79 EUDAMED record Report an error
Hantavirus / bunyavirus W0105040614 – 98/79 EUDAMED record Report an error
Hav antibody (total) W0105020102 – 98/79 EUDAMED record Report an error
Various instruments for cardiology and cardiac surgery - hardware accessories Z12059080 I, IIa, IIb MDR, 93/42 EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101 B IVDR EUDAMED record Report an error
Bacteriology - RT & POC - other W0105090199 – 98/79 EUDAMED record Report an error
Cardiac ablation equipment Z12059011 I, IIb MDR, 93/42 EUDAMED record Report an error
H. pylori - RT & POC W0105090102 – 98/79 EUDAMED record Report an error
Legionella antigen detection W0105010501 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 98/79 EUDAMED record Report an error
Various general purpose IVD instruments - consumables W02079085 A IVDR EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - hardware accessories Z12019080 I MDR EUDAMED record Report an error
Zika virus W0105040630 – 98/79 EUDAMED record Report an error
Bacteriology immunoassay - other W0105011799 – 98/79 EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105 A IVDR EUDAMED record Report an error
Controls - inf. immunology - other W0105080899 – 98/79 EUDAMED record Report an error
HCV antibody -RT & POC W0105090202 – 98/79 EUDAMED record Report an error
Hemostasis controls RT & POC W010302080501 C IVDR, 98/79 EUDAMED record Report an error
Histology / cytology reagents - other W01030799 A IVDR EUDAMED record Report an error
Immunochemistry readers W0201020201 A IVDR EUDAMED record Report an error
Invasive blood sugar monitoring systems, single-use sensors Z1204011585 IIa, IIb MDR EUDAMED record Report an error
IVD general use consumables devices - other accessories W0580 A IVDR EUDAMED record Report an error
Mycobacterial antigen detection W0105010701 – 98/79 EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Salmonella antibody assays W0105011002 – 98/79 EUDAMED record Report an error
Activated clotting time RT & POC W0103020804 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - consumables W0201020185 A IVDR EUDAMED record Report an error
Automated systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801 – 98/79 EUDAMED record Report an error
Blood glucose meters W0201060102 A IVDR EUDAMED record Report an error
Cardiac electrophysiology stimulators Z1205078001 I, IIb MDR EUDAMED record Report an error
Cardiac mapping equipment Z12059002 I, IIb MDR, 93/42 EUDAMED record Report an error
Chagas W0105050202 – 98/79 EUDAMED record Report an error
Chemistry analysers - consumables W0201010185 A IVDR EUDAMED record Report an error
Chemistry analysers - high routine (with ise mode test/h > 1.200) W0201010108 A IVDR EUDAMED record Report an error
Cmv - NA reagents W0105040205 C IVDR EUDAMED record Report an error
Cmv igg W0105040203 C IVDR EUDAMED record Report an error
Cmv igg - avidity W0105040206 C IVDR EUDAMED record Report an error
Cmv igm W0105040204 C IVDR, 98/79 EUDAMED record Report an error
Coronavirus igm W0105041104 – 98/79 EUDAMED record Report an error
Devices for samples analyses - other accessories W05039080 A, C IVDR EUDAMED record Report an error
Ebv - NA reagents W0105040403 C IVDR EUDAMED record Report an error
H. pylori antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Hav antibody igg W0105020103 B IVDR EUDAMED record Report an error
Hav antibody igm W0105020104 B IVDR EUDAMED record Report an error
Hsv 1 igg W0105040306 C IVDR EUDAMED record Report an error
Hsv 2 igg W0105040309 C IVDR EUDAMED record Report an error
Instruments for cardiological polygraphy - hardware accessories - other Z1205078099 IIb MDR, 93/42 EUDAMED record Report an error
Limited panel chemistry analysers - hardware accessories W0201010280 A IVDR EUDAMED record Report an error
Multiple infectious - multiplex assays - other W0105070599 – 98/79 EUDAMED record Report an error
Neurological stimulators Z12101106 III MDR EUDAMED record Report an error
Norovirus W0105040616 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables W02050185 A IVDR EUDAMED record Report an error
Other HPV - NA reagents W0105041005 C IVDR EUDAMED record Report an error
Parasitology controls - inf.imm. W0105080805 – 98/79 EUDAMED record Report an error
Pipettes, tips without filter W0503020202 A IVDR 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
Strep. pneumoniae - RT & POC W0105090109 – 98/79 EUDAMED record Report an error
Supplemental NA reagents W0105900103 A IVDR EUDAMED record Report an error
Toxoplasma antibody igg W0105050102 C IVDR EUDAMED record Report an error
Toxoplasma antibody igg - avidity W0105050104 C IVDR EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 C IVDR EUDAMED record Report an error
Various instruments for cardiology and cardiac surgery - consumables Z12059085 I MDR EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A IVDR EUDAMED record Report an error
Automated 3 part hematology analysers W0202010201 B IVDR EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) W0201020102 A IVDR EUDAMED record Report an error
Automated slide preparation units W02039004 A IVDR EUDAMED record Report an error
Automated slide stainers W0202059002 A IVDR EUDAMED record Report an error
Bk virus - NA reagents W0105040522 C IVDR EUDAMED record Report an error
Blood collection, capillary tubes W0501010203 A IVDR EUDAMED record Report an error
Cassette / slide printers W0202059017 A IVDR EUDAMED record Report an error
Cell counting instruments - other W02020199 A IVDR EUDAMED record Report an error
Cellular enzyme determination reagents (g-6-pdh, pyruvate kinase) W0103019001 – 98/79 EUDAMED record Report an error
Chemistry analysers - high routine (random access without ise mode test/h > 1.200) W0201010104 A IVDR EUDAMED record Report an error
Complete cardiography systems Z12050701 I, IIb MDR, 93/42 EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 B IVDR EUDAMED record Report an error
Devices for samples transport - other accessories W050280 A IVDR EUDAMED record Report an error
Gonococcal detection by NA reagents W0105010203 C IVDR EUDAMED record Report an error
Haematology / haemostasis / immunohaematology / histology / cytology reagents - other W010399 A IVDR EUDAMED record Report an error
Haematology reagents - other W01030199 A IVDR EUDAMED record Report an error
Hepatitis b surface antigen W0105020201 – 98/79 EUDAMED record Report an error
Hepatitis b surface antigen - confirmatory W0105020202 – 98/79 EUDAMED record Report an error
Hepatitis b virus - NA reagents W0105020216 D IVDR EUDAMED record Report an error
Hepatitis c virus (HCV) genotyping - NA reagents W0105020309 C IVDR EUDAMED record Report an error
Hepatitis c virus - NA reagents W0105020307 D IVDR EUDAMED record Report an error
HIV 1 - NA reagents W0105030107 D IVDR EUDAMED record Report an error
HIV ag/ab combi - RT & POC W0105090303 – 98/79 EUDAMED record Report an error
Infectious immunology instruments W0204 A IVDR EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 B IVDR EUDAMED record Report an error
Infusion pumps Z12030301 IIb MDR EUDAMED record Report an error
Limited panel immunochemistry analysers - other W0201020299 A IVDR EUDAMED record Report an error
Measurement devices - other V0399 I MDR EUDAMED record Report an error
Multilevel blood controls W0103010503 B IVDR EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 C IVDR EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 C IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other W02050199 A IVDR EUDAMED record Report an error
Pipettes, tips - accessories W0503020280 A IVDR EUDAMED record Report an error
Portable pain therapy instruments Z1204021602 I MDR EUDAMED record Report an error
Prothrombin time RT & POC W0103020801 C IVDR EUDAMED record Report an error
Robotic sample processing systems - consumables W02060185 A IVDR EUDAMED record Report an error
Robotic sample processing systems - hardware accessories W02060180 A IVDR EUDAMED record Report an error
Samples analyses, plastic containers - other W050301029099 A IVDR EUDAMED record Report an error
Samples analyses, plastic containers - other accessories W0503010280 A IVDR EUDAMED record Report an error
Samples analyses, plastic dishes for microtechniques W0503010204 A IVDR EUDAMED record Report an error
Samples collection devices - other W05019099 A IVDR EUDAMED record Report an error
Samples transport, containers - accessories W05020180 A IVDR EUDAMED record Report an error
Stain solutions (histology/cytology) W01030708 A IVDR EUDAMED record Report an error
Standards and calibrators infectious immunology - RT & POC W0105094002 – 98/79 EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501 C IVDR EUDAMED record Report an error
Various general purpose IVD instruments - hardware accessories W02079080 A IVDR EUDAMED record Report an error
Various general purpose IVD instruments - software accessories W02079082 A IVDR EUDAMED record Report an error
Various hematology / histology / cytology instruments - consumables W02029085 A IVDR EUDAMED record Report an error
Various instruments for cardiology and cardiac surgery - software accessories Z12059082 IIb 93/42 EUDAMED record Report an error
Various neurology and neurosurgery instruments - hardware accessories Z12109080 I MDR EUDAMED record Report an error
Various neurology and neurosurgery instruments - other Z12109099 IIb MDR EUDAMED record Report an error
Various ultrasound instruments - hardware accessories Z11049080 I MDR EUDAMED record Report an error
Whole blood calibrators W0103010507 B IVDR EUDAMED record Report an error

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