- The FDA announced the final rule for the Unique DeviceIdentification (UDI) system on September 23, 2013, which willmake it easier for manufacturers and regulators to identifyproblems with medical devices via adverse event reports.11 TheUDI system has two core el...
to maintaintraceabilityandtransparencythroughout the whole supply chain, from the MD (medical device) manufacturer to the patient and across the entire product life cycle. In 2013, the FDA (Food and Drug Administration) released the Unique Device Identification(UDI)of medical ...
激光和脉冲光工作站Medical Laser/ Pulse Light/ UV Device,产品由主控制台,手持器和脚踏开关组成。主控制台包括控制面板,电源指令舱,冷却系统,开关指令舱,服务面板,绝缘变压器; 手持器(连接有电缆以及连接器)包括光学头,组织冷却系统(冷却台)和手持器开关。,激光和
A transformation is needed to provide medical device manufacturers with the required traceability, quality and regulatorycompliancewhile eliminating non-value-added activities (EU MDR, UDI, ISO, FDA Case for Quality, 21 CFR part 11….). Data-drivenpredictive qualityhelps companies not only to avoid...
Hantech Medical Device Co., Ltd.的Disposable Insulin Pen Needle在2023年4月6日获得FDA 510(k)注册认证 一、注册产品概况 (一)产品及企业信息 1.产品基础信息 产品名称: Disposable Insulin Pen Needle k号: K222739 批准日期: 2023-04-06 申请企业: Hantech Medical Device Co., Ltd....
FDA Label Read More We offer a comprehensive suite of services for medical devices, covering a wide array of products such as reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices. Our expertise spans all device classes, from low...
The FDA have now released a final ruling requiring that medical devices distributed in the US, carry a unique device identifier, known as a UDI. This data is then submitted by the manufacturers to the FDA Global UDI Database (GUDID). ...
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产品分类名称: Blood Pressure Cuff产品分类定义: A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.法规编号: 870.1120GMP豁免: 否 2.申请企业信息...
Under the Food & Drug Administration's (FDA) rule in the United States, manufacturers have been required to implement Unique Device Identification (UDI) on all medical product packaging since September 2014. Now, in light of the recently adopted EU Medical Device Regulation (MDR), European ...