| 器械名称 | 根管锉 |
|---|---|
| 备案号 | 粤深械备20230726号 |
| 备案人名称 | 深圳市乐捷医疗器械有限公司 |
| 企业联系电话 | 暂无权限 |
| 备案人注册地址 | 深圳市龙岗区坂田街道岗头社区天安云谷产业园二期（0207地块）6栋3109 |
| 生产地址 | 广东省惠州市惠城区水口街道岃洛六路6号第五栋101、201、801房（委托惠州市德嘉医疗科技有限公司生产） |
| 型号规格 | Megabiodent The X File 17mm 17/08；Megabiodent The X File 17mm 25/09 Megabiodent The X File 17mm 20/10；Megabiodent The X File 17mm 17/12 Megabiodent The X File 19mm 17/08；Megabiodent The X File 19mm 25/09 Megabiodent The X File 19mm 20/10；Megabiodent The X File 19mm 17/12 Megabiodent The X File 21mm 15/02；Megabiodent The X File 21mm 19/02 Megabiodent The X File 21mm 20/02；Megabiodent The X File 21mm 14/03 Megabiodent The X File 21mm 15/04；Megabiodent The X File 21mm 10/04 Megabiodent The X File 21mm 13/04；Megabiodent The X File 21mm 17/04 Megabiodent The X File 21mm 20/04；Megabiodent The X File 21mm 25/04 Megabiodent The X File 21mm 30/04；Megabiodent The X File 21mm 35/04 Megabiodent The X File 21mm 40/04；Megabiodent The X File 21mm 45/04 Megabiodent The X File 21mm 50/04；Megabiodent The X File 21mm 55/04 Megabiodent The X File 21mm 60/04；Megabiodent The X File 21mm 70/04 Megabiodent The X File 21mm 80/04；Megabiodent The X File 21mm 15/05 Megabiodent The X File 21mm 15/06；Megabiodent The X File 21mm 20/06 Megabiodent The X File 21mm 25/06；Megabiodent The X File 21mm 30/06 Megabiodent The X File 21mm 35/06；Megabiodent The X File 21mm 40/06 Megabiodent The X File 21mm 45/06；Megabiodent The X File 21mm 50/06 Megabiodent The X File 21mm 55/06；Megabiodent The X File 21mm 60/06 Megabiodent The X File 21mm Assorted；Megabiodent The X File 25mm15/02 Megabiodent The X File 25mm 19/02；Megabiodent The X File 25mm 20/02 Megabiodent The X File 25mm 14/03；Megabiodent The X File 25mm 15/04 Megabiodent The X File 25mm 10/04；Megabiodent The X File 25mm 13/04 Megabiodent The X File 25mm 17/04；Megabiodent The X File 25mm 20/04 Megabiodent The X File 25mm 25/04；Megabiodent The X File 25mm 30/04 Megabiodent The X File 25mm 35/04；Megabiodent The X File 25mm 40/04 Megabiodent The X File 25mm 45/04；Megabiodent The X File 25mm 50/04 Megabiodent The X File 25mm 55/04；Megabiodent The X File 25mm 60/04 Megabiodent The X File 25mm 70/04；Megabiodent The X File 25mm 80/04 Megabiodent The X File 25mm 15/05；Megabiodent The X File 25mm 15/06 Megabiodent The X File 25mm 20/06；Megabiodent The X File 25mm 25/06 Megabiodent The X File 25mm 30/06；Megabiodent The X File 25mm 35/06 Megabiodent The X File 25mm 40/06；Megabiodent The X File 25mm 45/06 Megabiodent The X File 25mm 50/06；Megabiodent The X File 25mm 55/06 Megabiodent The X File 25mm 60/06；Megabiodent The X File 25mm Assorted Megabiodent The X File 31mm 15/02；Megabiodent The X File 31mm 19/02 Megabiodent The X File 31mm 20/02；Megabiodent The X File 31mm 14/03 Megabiodent The X File 31mm 15/04；Megabiodent The X File 31mm 10/04 Megabiodent The X File 31mm 13/04；Megabiodent The X File 31mm 17/04 Megabiodent The X File 31mm 20/04；Megabiodent The X File 31mm 25/04 Megabiodent The X File 31mm 30/04；Megabiodent The X File 31mm 35/04 Megabiodent The X File 31mm 40/04；Megabiodent The X File 31mm 45/04 Megabiodent The X File 31mm 50/04；Megabiodent The X File 31mm 55/04 Megabiodent The X File 31mm 60/04；Megabiodent The X File 31mm 70/04 Megabiodent The X File 31mm 80/04；Megabiodent The X File 31mm 15/05 Megabiodent The X File 31mm 15/06；Megabiodent The X File 31mm 20/06 Megabiodent The X File 31mm 25/06；Megabiodent The X File 31mm 30/06 Megabiodent The X File 31mm 35/06；Megabiodent The X File 31mm 40/06 Megabiodent The X File 31mm 45/06；Megabiodent The X File 31mm 50/06 Megabiodent The X File 31mm 55/06；Megabiodent The X File 31mm 60/06 Megabiodent The X File 31mm Assorted；Megabiodent The X File 16mm D1 Megabiodent The X File 18mm D2；Megabiodent The X File 22mm D3 Megabiodent The X File 16mm Assorted；Megabiodent The X File 18mm Assorted Megabiodent The X File 22mm Assorted |
| 产品描述 | 工作端采用镍钛合金材料制成，柄部采用硅胶注塑制成的手持器械。工作端有刻纹或螺旋刃口，起切削、平整的作用。无源产品。非无菌提供。使用前由使用机构根据说明书进行灭菌。 |
| 预期用途 | 用于牙科治疗中对牙骨、根管进行切削、平整、清洁、塑形。 |
| 备注 | \ |
| 备案单位 | 深圳市市场监督管理局 |
| 备案日期 | 2024-05-14 |
| 变更情况 | 2023年12月1日：备案人注册地址由“深圳市龙华区观湖街道上坑社区上围工业区金倡达科技园Ⅰ栋五楼”变更为“深圳市龙岗区坂田街道岗头社区天安云谷产业园二期（02-07地块）6栋3109”；生产地址由“深圳市龙华区观湖街道上坑社区上围工业区金倡达科技园Ⅰ栋五楼”变更为“广东省惠州市惠城区水口街道岃洛六路6号第五栋301A号房（委托深圳市乐捷医疗器械有限公司惠州市分公司生产）”；新增受托方企业信息，受托方企业名称：深圳市乐捷医疗器械有限公司惠州市分公司，受托方统一社会信用代码：91441302MACFBL8L2R；；2024年5月14日：生产地址由“广东省惠州市惠城区水口街道岃洛六路6号第五栋301A号房（委托深圳市乐捷医疗器械有限公司惠州市分公司生产）”变更为“广东省惠州市惠城区水口街道岃洛六路6号第五栋101、201、801房（委托惠州市德嘉医疗科技有限公司生产）”；受托方企业信息由“受托方企业名称：深圳市乐捷医疗器械有限公司惠州市分公司，受托方统一社会信用代码：91441302MACFBL8L2R”变更为“受托方企业名称：惠州市德嘉医疗科技有限公司，受托方统一社会信用代码：91441302MACBEPQK26”。 |
| 备案类型 | 暂无权限 |
扩展信息
