1,239 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: China
×
Dongguan CFE Electronic Co., Ltd
FDA registration
Dongguan CFE Electronic Co., Ltd·2 products·🇨🇳 China
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED
FDA registration
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED·6 products·🇨🇳 China
AFO
Device
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·On the market
AFO
Device
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·On the market
AFO
Device
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·On the market
AFO
Device
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·On the market
OPHTHALMIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·CJO(Shanghai) Technology Co., Ltd·On the market·32 countries
AFO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·1 device
AFO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·1 device
AFO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·1 device
AFO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Xiamen LongStar Medical Equipment Co., Ltd·1 device
Easy-CF2
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Pilot Gene Technology (Hangzhou) Co., Ltd·1 device
Mirror Chart
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·CJO(Shanghai) Technology Co., Ltd·1 device
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·BrosMed Medical Co.,Ltd.·March 6, 2019
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
FDA Enforcement
Class II
·Terminated·Getinge (Suzhou) Co Ltd·June 9, 2021
Philips Incisive CT
FDA Enforcement
Class II
·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 14, 2026
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
CMS8000 Patient Monitor
FDA Enforcement
Class II
·Ongoing·Contec Medical Systems Co., Ltd.·May 21, 2025
AcoSound. Model Number: LW12-BTE-M
FDA Enforcement
Class III
·Ongoing·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.·June 25, 2025