Results for “Hematology Analyzer LYSE”

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Registry EUDAMED 289 FDA 510(k) incl. De Novo 1 FDA PMA GUDID

Country / market European Union (all) 273 United States 1

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Germany 237 Ireland 15 Spain 12 France 8 Iceland 6 Austria 1

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

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Class A 280 Class B Class C Class D IVD General 9 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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Hematology Analyzer Lyse

Shenzhen Dymind Biotechnology Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A
Lyse for Hematology Analyzers Use

Labnovation Technologies, Inc.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A

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Results for “Hematology Analyzer LYSE”

Category (EMDN)

Hematology Analyzer Lyse

Lyse for Hematology Analyzers Use