产品名称(中文) | 口腔颌面锥形束计算机体层摄影设备 |
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产品名称(英文) | Dental Cone-beam Computed Tomography |
结构及组成/主要组成成分 | 该产品由X射线管头、影像接收器(CBCT摄影及曲面体层摄影平板探测器,头影测量探测器)、控制装置、辅助定位装置、机架、工作站软件组成。头影测量探测器仅适用于产品型号ICT-R01-L。 |
适用范围/预期用途 | 该产品供医疗机构用于口腔颌面部X射线影像检查,包括X射线锥形束计算机体层摄影、曲面体层摄影、头影测量摄影(仅适用于产品型号ICT-R01-L)。 |
型号规格 | ICT-R01,ICT-R01-L |
注册证编号 | 国械注进20193060615 |
注册人名称(中文) | 登腾株式会社 |
注册人名称(英文) | Dentium Co., Ltd. |
注册人住所 | 9F, 10F 76Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi-do,Korea Rep |
生产地址 | (1)150,Eondong-ro,Giheung-gu, Yongin-si, Gyeonggi-do, Korea (2)9F, 10F 76 Changnyong-daero 256beon-gil, Yeongtong- gu, Suwon-si Gyeonggi-do,Korea Rep. (3)Lot A18-1, Road No.12, Da Nang High-Tech Park,Hoa LienCommune, Hoa Vang District, Da Nang City.Vietnam |
代理人名称 | 登腾(北京)医疗器械商贸有限公司 |
代理人住所 | 北京市顺义区林河经济开发区林河大街22号院13号楼5层501室(科技创新功能区) |
编码代号2018 | 暂无权限 |
管理类别 | 暂无权限 |
批准日期 | 2019-12-09 |
有效期至 | 2024-12-08 |
变更情况 | 2020-07-02 此次变更包括生产地址变更和注册人住所变更1、生产地址由"#201, #401, 150, Eondong-ro,Giheung-gu, Yongin-si,Gyeonggi-do, Korea"变更为:"(1)150,Eondong-ro,Giheung-gu, Yongin-si, Gyeonggi-do, Korea (2)8F, 9F 76 Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi-do,Korea Rep. (3)Lot A18-1, Road No.12, Da Nang High-Tech Park,Hoa Lien Commune, Hoa Vang District, Da Nang City.Vietnam";2、注册人住所由"#201, #401, 150, Eondong-ro,Giheung-gu, Yongin-si,Gyeonggi-do, Korea"变更为:"8F, 9F 76 Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi-do,Korea Rep. " 2021-01-26 “代理人住所:北京市朝阳区来广营西路5号院3号楼11层03-05号”变更为“代理人住所:北京市顺义区林河经济开发区林河大街22号院13号楼5层501室(科技创新功能区)”。 2023-03-31 注册人住所由8F, 9F 76 Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi-do,Korea Rep ;变更为:9F, 10F 76Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi-do,Korea Rep 2023-05-17 生产地址由(1)150,Eondong-ro,Giheung-gu, Yongin-si, Gyeonggi-do, Korea (2)8F, 9F 76 Changnyong-daero 256beon-gil, Yeongtong- gu, Suwon-si Gyeonggi-do,Korea Rep. (3)Lot A18-1, Road No.12, Da Nang High-Tech Park,Hoa LienCommune, Hoa Vang District, Da Nang City.Vietnam变更为:(1)150,Eondong-ro,Giheung-gu, Yongin-si, Gyeonggi-do, Korea (2)9F, 10F 76 Changnyong-daero 256beon-gil, Yeongtong- gu, Suwon-si Gyeonggi-do,Korea Rep. (3)Lot A18-1, Road No.12, Da Nang High-Tech Park,Hoa LienCommune, Hoa Vang District, Da Nang City.Vietnam |
指导原则 | 暂无权限 |
相关标准 | 暂无权限 |
临床路径 | 暂无权限 |
共性问题 | 暂无权限 |
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