QWY
- 产品代码
- QWY
- 器械名称
- Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
- 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
Intended for use at the patients point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo.
FDA 官方分类页: QWY
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。