REK

Research Laser

产品代码
REK
器械名称
Research Laser
管理类别
第 N 类(Not Classified)
FDA 专业组
Unknown
标记
豁免 GMP(质量体系)

FDA 分类定义

Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research.

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: REK
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。