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Emdyca

Manufacturer

Becton Dickinson

United StatesLegal entities : Becton, Dickinson and Company

Markets : Austria · Belgium · Finland · France · Germany · Ireland · Italy · Luxembourg · Netherlands · Poland · Spain · UK · United States

Approvals : EU – class I, IIa, A, B, C · United States (FDA) – 510(k) : 348 · PMA : 1 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 377 · Italy 130 · Spain 104 · Belgium 29 · Poland 28 · Germany 17 · Austria 6 · Netherlands 3 · Ireland 2 · Luxembourg 2 · Finland 1 · UK 1

EU representative : Becton Dickinson Ireland Limited (Ireland)

Website eudamedenquiries@bd.com

52 categories, 91 models including 91 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Blood collection, tubes with additives or serum separator W050101010201
2 others
 A IVDR, 98/79 EUDAMED record Report an error
Urine collection, tubes W05010202
1 other
 – 98/79 EUDAMED record Report an error
Dispensers W02079003 A IVDR EUDAMED record Report an error
Instruments for blood cultures and mycobacteria - other W02030299 A IVDR EUDAMED record Report an error
Laboratory instruments for microscopic investigations - consumables W0202050385 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables W02050185 A IVDR EUDAMED record Report an error
Automated blood culture analysers W02030201 A IVDR EUDAMED record Report an error
Fixing reagents (histology/cytology) W01030705 A IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Streptococcal reagents - other W0105011199 B IVDR EUDAMED record Report an error
Blood collection, capillary tubes W0501010203 A IVDR EUDAMED record Report an error
Capillary blood collection devices - accessories W0501010280 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - software accessories W02050182 A IVDR EUDAMED record Report an error
Robotic sample processing systems - hardware accessories W02060180 A IVDR EUDAMED record Report an error
Robotic sample processing systems - other W02060199 A IVDR EUDAMED record Report an error
Urine collection devices - other W05010299 – 98/79 EUDAMED record Report an error
Various microbiology instruments - consumables W02039085 A IVDR EUDAMED record Report an error
Antibiotic susceptibility analysers - hardware accessories W0203010180 A IVDR EUDAMED record Report an error
Automated slide stainers W0202059002 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
Blood collection, tubes without additives or serum separator W050101010202 A IVDR EUDAMED record Report an error
Blood gas samples collection, syringes without needle W0501010103 A IVDR EUDAMED record Report an error
C.difficile by NA reagents W0105011804 B IVDR EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 B IVDR EUDAMED record Report an error
Diluters W02079002 A IVDR EUDAMED record Report an error
Histology / cytology reagents - other W01030799 A IVDR EUDAMED record Report an error
HPV reagents - other W0105041099 A IVDR EUDAMED record Report an error
Microbiological culture devices - other W0503030199 A IVDR EUDAMED record Report an error
Mixed panel multiparameter analysers - software accessories W0201030182 A IVDR EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 A IVDR EUDAMED record Report an error
Mycobacterial antigen detection W0105010701 C IVDR EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 C IVDR EUDAMED record Report an error
Nephelometers W0201020204 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - hardware accessories W02050180 A IVDR EUDAMED record Report an error
Other HPV - NA reagents W0105041005 C IVDR EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 C IVDR EUDAMED record Report an error
Samples analyses, plastic tubes with additives W050301020101 A IVDR EUDAMED record Report an error
Samples analyses, plastic tubes without additives W050301020102 A IVDR EUDAMED record Report an error
Sputum collection devices W05019003 A IVDR EUDAMED record Report an error
Stain solutions (histology/cytology) W01030708 A IVDR EUDAMED record Report an error
Staphylococcal detection by NA reagents W0105011203 C IVDR EUDAMED record Report an error
Staphylococci reagents - other W0105011299 B IVDR EUDAMED record Report an error
Strep. b detection by NA reagents W0105011104 C IVDR EUDAMED record Report an error
Urine collection devices - accessories W05010280 A IVDR EUDAMED record Report an error
Urine collection, containers W05010203 – 98/79 EUDAMED record Report an error
Various hematology / histology / cytology instruments - consumables W02029085 A IVDR EUDAMED record Report an error
Various hematology / histology / cytology instruments - other W02029099 A IVDR EUDAMED record Report an error
Various microbiology instruments - IVD medical device software W02039092 A IVDR EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A IVDR EUDAMED record Report an error
Venous or arterious blood collection devices - other W0501010199 I MDR EUDAMED record Report an error
Vital signs monitoring instruments - consumables Z12030285 IIa MDR EUDAMED record Report an error
Vital signs monitoring instruments - other Z12030299 IIa MDR 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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