| 器械名称 | 人体定位垫 |
|---|---|
| 备案号 | 粤穗械备20150058号 |
| 备案人名称 | 广州科莱瑞迪医疗器材股份有限公司 |
| 企业联系电话 | 暂无权限 |
| 备案人注册地址 | 广州市经济技术开发区沙湾三街14号一至六楼 |
| 生产地址 | 广州市经济技术开发区沙湾三街14号一楼、二楼203、204房、三楼、四楼404房 |
| 型号规格 | R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RG570-S、RG550-CEL2、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M、R550-HS3、RV550-H1、 RV550-T1、R550-T1、R550-U2、R550-H2、R550-U3、RV550-HS3、RV550-CEL、RV550-M2、R550-CEL3、RG550-H3、RG550-CEL4、RG560-SH1A、RG550-H4、RG560-SH6、RG560-SH7、RG570-S3、RG570-S4、R580-E1 |
| 产品描述 | 采用热塑性材料制成。 |
| 预期用途 | 用于放射治疗过程中患者固定。 |
| 备案单位 | 广州市市场监督管理局 |
| 备案日期 | 2023-04-28 |
| 变更情况 | 2016年06月24日,备案人名称由 “广州科莱瑞迪医疗器材有限公司” 变更为 “广州科莱瑞迪医疗器材股份有限公司” 2016年06月24日,备案人组织机构代码由 “72564194-8” 变更为 “91440116725641948J” 2016年06月24日,型号/规格由 “详见产品技术要求中规范性附录A” 变更为 “R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1、RV550-HS1、RV550-HS2、RV550-L、RV550-M” 2016年06月24日 产品技术要求变更; 2017年02月21日,备案人注册地址由“广州经济技术开发区蓝玉四街9号广州科技园三号厂房六楼”变更为“广州市经济技术开发区沙湾三街14号一至六楼”;生产地址由“广州经济技术开发区蓝玉四街9号广州科技园三号厂房六楼，二楼202，一楼102”变更为“广州市经济技术开发区沙湾三街14号一至六楼”; 2018年07月18日,生产地址由“广州市经济技术开发区沙湾三街14号一至六楼”变更为“广州市经济技术开发区沙湾三街14号一楼、二楼203、204房、三楼、四楼404房”。 2018年09月19日,型号/规格由“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1、RV550-HS1、RV550-HS2、RV550-L、RV550-M”变更为“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1”。 产品技术要求变更。 2019年03月06日,型号/规格由“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1”变更为“R550- H1、 R550- HS1、R550- L、 R550- M、 R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、 RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2”。 产品技术要求变更。 2019年05月07日,型号/规格由“R550- H1、 R550- HS1、R550- L、 R550- M、 R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、 RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2”变更为“R550- H1、R550- HS1、R550- L、R550- M、R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400”。 产品技术要求变更。 2019年07月17日,型号/规格由“R550- H1、R550- HS1、R550- L、R550- M、R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400”变更为“R550- H1、 R550- HS1、R550- L、 R550- M、 R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、 RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400、RG570-S、RG550-CEL2、R550-S1、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1”。 产品技术要求变更。 2019年09月05日,型号/规格由“R550- H1、 R550- HS1、R550- L、 R550- M、 R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、 RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400、RG570-S、RG550-CEL2、R550-S1、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1”变更为“R550- H1、 R550- HS1、R550- L、 R550- M、 R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、 RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400、RG570-S、RG550-CEL2、R550-S1、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3”。 产品技术要求变更。 2021年07月05日,型号/规格由“R550- H1、 R550- HS1、R550- L、 R550- M、 R550- S、R550- T、R570- S、R570- Sl 、RV550- HS1、RV550- HS2、RV 550- L、 RV 550- M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400、RG570-S、RG550-CEL2、R550-S1、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3”变更为“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400、RG570-S、RG550-CEL2、R550-S1、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M”。 产品技术要求变更。 2022年01月19日,型号/规格由“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-T2L、R550-HS2L、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RSX-L400、RG570-S、RG550-CEL2、R550-S1、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M”变更为“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RG570-S、RG550-CEL2、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M、R550-HS3、RV550-H1、RV550-T1、R550-T1、R550-U2、R550-H2、R550-U3、RV550-HS3、RV550-CEL、RV550-M2、R550-CEL3、RG550-H3、RG550-CEL4、RG560-SH1A”；预期用途由“用于放疗患者的体位固定。”变更为“用于放射治疗过程中患者固定。”；产品描述由“放疗中的固定袋，头颅固定架，体部固定架，各类托架、托板，聚氨酯定型头枕，可塑固定面膜等都属于放疗定位设备。”变更为“采用热塑性材料制成。”。 产品技术要求变更。 2022年05月10日,型号/规格由“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RG570-S、RG550-CEL2、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M、R550-HS3、RV550-H1、RV550-T1、R550-T1、R550-U2、R550-H2、R550-U3、RV550-HS3、RV550-CEL、RV550-M2、R550-CEL3、RG550-H3、RG550-CEL4、RG560-SH1A”变更为“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RG570-S、RG550-CEL2、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M、R550-HS3、RV550-H1、RV550-T1、R550-T1、R550-U2、R550-H2、R550-U3、RV550-HS3、RV550-CEL、RV550-M2、R550-CEL3、RG550-H3、RG550-CEL4、RG560-SH1A、RG550-H4”。 产品技术要求变更。 2023年04月28日,型号/规格由“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RG570-S、RG550-CEL2、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M、R550-HS3、RV550-H1、RV550-T1、R550-T1、R550-U2、R550-H2、R550-U3、RV550-HS3、RV550-CEL、RV550-M2、R550-CEL3、RG550-H3、RG550-CEL4、RG560-SH1A、RG550-H4”变更为“R550-H1、R550-HS1、R550-L、R550-M、R550-S、R550-T、R570-S、R570-S1 、RV550-HS1、RV550-HS2、RV550-L、RV550-M、R550-U、R550-M1、R550-M3、R550-L2、R550-TL、R550-T2、R550-P、R550-CEL、R550-BOS、R550-BOS3、R550-S1、RV550-U1、RV550-S1、RV560-SH1、RV560-SH2、RV570-S、RV570-S1、R550-CEL2、R550-M2、R560-SH1、R560-SH5、RG570-S、RG550-CEL2、RG550-M、RG550-H2、RG550-S1、RG560-SH1、RG560-SH5、RG570-S1、RG560-SH2、RG560-SH3、R560-M、R570-M、R550-HS3、RV550-H1、 RV550-T1、R550-T1、R550-U2、R550-H2、R550-U3、RV550-HS3、RV550-CEL、RV550-M2、R550-CEL3、RG550-H3、RG550-CEL4、RG560-SH1A、RG550-H4、RG560-SH6、RG560-SH7、RG570-S3、RG570-S4、R580-E1”。 产品技术要求变更。 |
| 备案类型 | 暂无权限 |
扩展信息
