14 results
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76ms
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Sources: EU EUDAMED, US FDA
Guangzhou Pluslife Biotech Co., Ltd
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·3 Importers
Pluslife Dock Pro 8
Device
EU IVDR
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Eu Ivd Class A
·Guangzhou Pluslife Biotech Co., Ltd·On the market
Pluslife
Device
EU IVDR
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Eu Ivd Class A
·Guangzhou Pluslife Biotech Co., Ltd·On the market·1 country
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 Recall
Open, Classified
·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025
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 Recall
Open, Classified
·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025
Eight-Channel POC Molecular Analyzer
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Guangzhou Pluslife Biotech Co., Ltd·1 device
Integrated Nucleic Acid Testing Device
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Guangzhou Pluslife Biotech Co., Ltd·1 device
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
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
aprimeo diagnostics GmbH & Co. KG
Importer
🇩🇪 Germany·1 Manufacturer
audasia GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Haemato Pharm GmbH
Importer
🇩🇪 Germany·2 Manufacturers
PureCE B.V.
Authorized representative
🇳🇱 Netherlands·38 Manufacturers·468 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices