1
关注
909
浏览

If separately registered, do theyhave to clarify the matching situation?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:47

The generator and surgical accessories of high frequencysurgical equipment can either be submitted registration as the wholeproduct, or separately.

High frequency surgical equipment used for normal cutting andcoagulation is generallyconsidered as commonly universality. If theyare submitted separately, the matching situation does not need to beclarifed.
The high frequency generator shall clarify its connection portand the rated power, maximum output voltage, and crest factor ofeach output mode. The high frequency surgical instrument shallclarify its connection port and the maximum rated accessory voltageIf the connection port and parameters from two sides match, they willbe able to use together.

For unconventionality used cutting and coagulation function ofthe high frequency generator and accessories, the matching situationshall be clarified.

关于作者

问题动态

发布时间
2023-09-17 22:46
更新时间
2023-09-17 22:47
关注人数
1 人关注

推荐内容

注册申请人住所以及医疗器械生产许可证的地址为某大厦的二层、三层、四层。其中二层生产无菌器械,三层生产有源器械,四层为行政办公室。申报注册二类有源器械,生产地址可否写二层、三层、四层?
已取得医疗器械注册证的胶体金定性(肉眼判读)试纸条产品,增加配套仪器进行定性判读,可以变更注册么?
一次性使用血液透析管路的生物相容性评价研 究需注意的方面?
上市的产品包括硬件和软件组件,如将软件组件做为独立软件进行注册,且预期用途与功能都不变的情况下,同品种临床评价中可以将原产品中的软件组件做为对比器械进行同品种对比吗?
产品的适用范围是否一定与临床评价同品种完全一致?
企业参考品相关信息是否要写入技术要求?
球囊扩张导管产品技术要求中额定爆破压指标应如何制定?
血液透析浓缩物产品注册申报时,产品检测报告中应关注哪些内容?
体外诊断试剂临床试验的受试人群有哪些要求?
哪些内容发生变化应当申请第一类医疗器械产品变更备案?