RIM
- 产品代码
- RIM
- 器械名称
- Laser Marker, Cutter, Or Engraver, Tabletop, Consumer
- 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
A laser intended for consumer, non-industrial, applications to mark, cut, or engrave objects with text, logos, etc. using either a mask or a scanned laser beam in a portable/tabletop/desktop size, often marketed as do it yourself (DIY) tools.
FDA 官方分类页: RIM
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。