277 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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OPHTHALMIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·CJO(Shanghai) Technology Co., Ltd·On the market·32 countries
BED SUPPORTS
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU COCO HEALTHCARE PRODUCTS CO., LTD.·On the market·32 countries
NET PANTS
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU COCO HEALTHCARE PRODUCTS CO., LTD.·On the market·32 countries
INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU COCO HEALTHCARE PRODUCTS CO., LTD.·On the market·32 countries
Automatic Hematology Analyzer CC-5 Cell Clean A
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Maccura Biotechnology Co., Ltd. ·1 device
Mirror Chart
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·CJO(Shanghai) Technology Co., Ltd·1 device
Underpad / Changing Pads / Bed Pads
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·HANGZHOU COCO HEALTHCARE PRODUCTS CO., LTD.·1 device
Adult Pants / Adult Incontinence Underwear / Protective Underwear
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·HANGZHOU COCO HEALTHCARE PRODUCTS CO., LTD.·1 device
Adult Diaper / Adult Brief with Tabs / All-in-ones
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·HANGZHOU COCO HEALTHCARE PRODUCTS CO., LTD.·1 device
G2 102935 0002
Certificate
MDD Annex V·JIANGSU COOPWIN MED S & T CO.,LTD·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
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
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024