Results for “Specimen Collection Kit”

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Registry EUDAMED 209 FDA 510(k) incl. De Novo 16 FDA PMA GUDID 25

Country / market European Union (all) 145 United States 41

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Türkiye 61 Germany 44 Spain 29 Denmark 23 Ireland 23 Belgium 11 Austria 8 Italy 3 Netherlands 3 France 1

Risk class Class I 23 Class IIa 1 Class IIb Class III Class II (US) 18

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Class A 200 Class B Class C Class D IVD General 4 IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)

Zhejiang Aicor Medical Technology Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A

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Results for “Specimen Collection Kit”

Category (EMDN)

Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)