| 一、冲牙器-各国分类及依据 | ||
| 中国-非医械 | 根据2019年第一批医疗器械产品分类界定结果汇总 | |
| 日本-I类 |
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| 美国-I类 |
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| 欧洲-IIa类 | Rule5 All invasive devices with respect to body orifices, other than surgically invasive devices,intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa | |
| 沙特-B类 | 参照欧盟法规 | |
| 东南亚-B类 | Rule5 All invasive medical devices with respect to body orifices (otherthan those which are surgically invasive) that are intended to be connected to an active medical device in Class B or a higher class,are in Class B. | |
| 二、洗鼻器(电动)-各国分类及依据 | ||
| 中国-II类 |
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| 日本-II类 |
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| 美国-I类 |
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| 欧洲-IIa类 |
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| 沙特-B类 | 参照欧盟法规 | |
| 东南亚-B类 | Rule5 All invasive medical devices with respect to body orifices (other than those which are surgically invasive) that are intended to be connected to an active medical device in Class B or a higher class,are in Class B. | |
| 三、洗鼻器(手动)-各国分类及依据 | ||
| 中国-非医械 | 根据2020年第一批医疗器械产品分类界定结果汇总,鼻腔冲洗剂和婴儿吸鼻器不再作为医疗器械。 | |
| 日本-I类 |
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| 美国-I类 | / | |
| 欧洲-I类 |
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| 沙特-A类 | 参照欧盟法规 | |
| 东南亚-A类 | 参照欧盟法规 | |
| 四、电动牙刷-各国分类及依据 | ||
| 中国-非医械 | 根据2023年第一次医疗器械产品分类界定结果汇总 | |
| 日本-非医械 | 医用牙科清洁 工具属于Ⅰ类; A kit that contains a prophylactic treatment brush, prophylactic cup, dental floss, and abrasive. The kit is used by a dentist and dental hygienist for tooth surface cleaning-class Ⅰ | |
| 美国-I类 |
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| 欧洲-非医械 | / | |
| 沙特-IIa类 |
吸力牙刷、用于口腔卫生的牙刷-Ⅱa | |
| 东南亚 |
在菲律宾属于A类医疗器械 | |
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