1,579 results · 11ms · Sources: EU EUDAMED, US FDA

Immunochromatography AI Reader

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EU IVDR · Eu Ivd Class A ·Shenzhen Everbest Machinery lndustry Co., Ltd.·1 device

Fluid Pack Prolyte CA

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EU IVDR · Eu Ivd Class A ·Diamond Diagnostics Inc·1 device

AI-Libre Urinalysis System

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EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·3 devices

Array Imaging System (AIS)

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EU IVDR · Eu Ivd Class A ·BioArray Solutions Ltd·1 device

AUTION EYE (AI-4510)

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EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

Estriol (CLIA)、Estriol Calibrators

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EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Angio-I(A I) Detection Kit(CLIA)

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EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

Aiforia® Clinical AI Model for Breast Cancer; Ki67

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EU IVDD · Eu Ivd General ·Aiforia Technologies Plc·1 device

Aiforia® Clinical AI Model for Breast Cancer; PR

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EU IVDD · Eu Ivd General ·Aiforia Technologies Plc·1 device

Aiforia® Clinical AI Model for Breast Cancer; ER

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EU IVDD · Eu Ivd General ·Aiforia Technologies Plc·1 device

Aiforia® Clinical AI Model for Lung Cancer; PD-L1

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EU IVDD · Eu Ivd General ·Aiforia Technologies Plc·1 device

Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups

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EU IVDD · Eu Ivd General ·Aiforia Technologies Plc·1 device

Norma-iDil5

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EU IVDR · Eu Ivd Class A ·NORMA Instruments Zártkörűen Működő Részvénytársaság·1 device

NanoTYPE

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EU IVDR · Eu Ivd Class C ·Omixon Biocomputing Ltd.·3 devices

PANNORAMIC 150 DX Digital Scanner

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EU IVDR · Eu Ivd Class A ·3DHISTECH Kft.·1 device

PANNORAMIC 75 DX Digital Scanner

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EU IVDR · Eu Ivd Class A ·3DHISTECH Kft.·1 device

PANNORAMIC Flash DESK DX Digital Scanner

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EU IVDR · Eu Ivd Class A ·3DHISTECH Kft.·2 devices

ProLyte Electrolyte Analyzer

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EU IVDR · Eu Ivd Class A ·Diamond Diagnostics Inc·1 device

Abacus 380 hematology analyzer

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EU IVDR · Eu Ivd Class A ·Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság·8 devices

Aquila Hematology Analyzer

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EU IVDR · Eu Ivd Class A ·Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság·4 devices