MDS

Sensor, Glucose, Invasive

产品代码: MDS
器械名称: Sensor, Glucose, Invasive
管理类别: 第 3 类（Class III）
FDA 专业组: Unknown
上市路径: 需 PMA 上市前批准

FDA 分类定义

The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： MDS

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。