12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Shenzhen Edge Medical Co., Ltd.
Manufacturer
🇨🇳 China
Begg
Device
EU MDR
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Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·On the market·4 countries
Begg
Device
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·On the market·4 countries
Begg
Device
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·On the market·4 countries
Begg
Device
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·On the market·4 countries
Begg
Device
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·On the market·4 countries
Begg
Device
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·On the market·4 countries
FMR1 CGG PCR
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Beijing Healthgene Laboratory Co.,Ltd·1 device
FMR1 CGG PCR
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Beijing Healthgene Laboratory Co.,Ltd·1 device
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No
FDA Enforcement
Class II
·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO
FDA Enforcement
Class II
·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
FDA Enforcement
Class II
·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025