1
关注
1269
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

相关问题

推荐内容

医疗器械产品没有互联网连接,是否不适用于网络安全要求?
不同类型的瓷粉或瓷块,如果有一种类型产品的化学成分可以包括其他类型的产品,是否可以仅选择该类型产品进行生物相容性试验?
无源医疗器械发生变化时,何种情况需考虑对其安全性进行重新评价?
YY 0286.1-2019中药液过滤器排气孔细菌截留性能评价方法如何选择?
关于种植体产品综述资料中结构设计的器械特征应考虑哪些方面?
纯钦或镇合金材料的骨科植入器械经着色阳极氧化处理后,如产品表面除基体元素外还含有残留杂质元素应如何进行生物学评价?
若骨科、口腔植入产品的原材料来源于两家供应商,需进行哪些验证?
注册申请人通过自检方式提交产品检验报告的,应当提交哪些申报资料?
骨科植入器械金属涂层的性能评价应关注哪些 方面?
在注册证有效期内的产品,发布了新的推荐性行标,不是国参,请问老师,我们需要根据推荐性行标进行注册变更吗?