人体定位袋-粤禅械备20230042号-器械数据

产品名称：

人体定位袋

注册人名称：

广东美岑医疗设备有限公司

注册(备案)号：

粤禅械备20230042号

注册人住所：

佛山市南海区狮山镇小塘工业大道五星段82号万洋创智园5栋（住所申报）

批准(备案)日期：

2026-02-04

结构及组成：

由袋体、填充泡沫颗粒(尼龙复合材料、EPS发泡粒子)和气嘴组成。抽真空可成形。

适用范围：

用于放射治疗过程中患者定位和固定。

变更情况：

变更情况：2026年02月04日，型号/规格变更为RC-D0001、RC-D0002、RC-D0003、RC-D0004、RC-E0001、RC-E0002、RC-E0003、RC-E0004、RC-E0005、RC-E0006、RC-E0007、RC-L0001、RM-E0001、RC-D1001、RC-D1002、RC-D1003、RC-D1004、RC-D1005、RC-D1006、RC-D1007、RC-D1008、RC-E1001、RC-E1002、RC-E1003、RC-E1004、RC-E1005、RC-E1006、RC-E1007、RC-E1008F、RC-E1009F、RC-E1010S、RC-L1001、RM-E1001F、RM-E1002、RC-D2001、RC-D2002、RC-D3001、RC-D3002F、RC-E3001、RC-E3002F、RC-E3003F、RC-E3004F、RC-E3005F、RC-E3006F、RC-E3007F、RC-E3008F、RC-E3009F、RC-E3010F、RC-E3011F、RC-E3012F、RC-E3013F、RC-E3014F、RC-E3015F、RC-E3016F、RC-E3017F、RC-E3018F、RC-E3019、RM-E3001S、RM-E3002、RC-B4001F、RC-B4002、RC-D4001、RC-D4002、RC-D4003、RC-D4004、RC-D4005、RC-D4006、RC-D4007、RC-E4001、RC-E4002、RC-E4003、RC-E4004、RC-E4005、RC-E4006、RC-E4007、RC-E4008F、RC-E4009、RC-E4010F、RC-E4011F、RC-E4012、RC-E4013、RC-E4014F、RC-E4015F、RC-E4016、RC-E4017、RC-E4018F、RC-B5001S、RC-B5002、RC-B5003S、RC-B5004、RC-D5001、RC-D5002、RC-D5003、RC-D5004、RC-D5005、RC-D5006、RC-D5007、RC-D5008、RC-D5009、RC-D5010、RC-D5011、RC-D5012、RC-D5013、RC-D5014、RC-D5015、RC-D5016、RC-D5017、RC-D5018、RC-D5019、RC-D5020、RC-D5021、RC-D5022、RC-D5023、RC-D5024、RC-D5025、RC-D5026、RC-D5027、RC-D5028、RC-D5029、RC-D5030、RC-E5001、RC-E5002、RC-E5003、RC-E5004F、RC-E5005S、RC-E5006S、RC-E5007、RC-E5008、RC-E5009F、RC-E5010、RC-E5011F、RC-E5012S、RC-E5013、RC-E5014、RC-E5015、RC-E5016、RC-E5017、RC-E5018、RC-E5019、RC-E5020、RC-E5021F、RC-E5022、RC-E5023S、RC-E5024、RC-E5025S、RC-E5026S、RC-E5027、RC-E5028F、RC-E5029、RC-E5030、RC-E5031、RC-E5032、RC-E5033S、RC-E5034、RC-E5035、RC-E5036、RC-E5037、RC-E5038、RC-E5039、RC-L5001、RC-L5002、RC-L5003、RC-L5004、RC-L5005、RC-L5006、RM-B5001、RM-D5001、RM-E5002、RM-E5003、RM-E5007、RM-E5008、RM-E5010、RC-D6001、RC-D6002、RC-D6003、RC-D6004、RC-E6001、RC-E6002、RC-E6003、RC-L6001、RC-D7001、RC-B8001S、RC-D8001、RC-D8002、RC-E8001、RC-E8002、RC-E8003、RC-E8004S、RC-E8005、RC-E8006、RC-E8007、RC-E8008、RC-E8009、RC-E8010、RC-E8011S、RC-E8012、RC-E8013S、RC-E8014、RC-E8015、RC-E8016、RC-E8017、RC-E8018、RC-L8001、RC-L8002、RM-E8001、RM-E8003、RM-B5001S、RM-D0003、RM-D1001、RM-D1003、RM-D3002F、RM-D5010、RM-D5016、RM-D7001、RM-D8001、RM-E1003、RM-E1004、RM-E1005、RM-E3005F、RM-E3010F、RM-E3019、RM-E4003、RM-E4004、RM-E4013、RM-E4014F、RM-E5001、RM-E5004F、RM-E5005S、RM-E5006S、RM-E5009F、RM-E5011F、RM-E5012S、RM-E5013、RM-E5016、RM-E5020、RM-E5021F、RM-E5023S、RM-E5024、RM-E5025S、RM-E5026S、RM-E5027、RM-E5032、RM-E5033S、RM-L5001、RM-E8002、RM-E8005、RM-E8006、RM-E8011S、RM-E8012、RC-E1011F、RC-E3020F、RC-E4019、RM-E5036、RC-E0008、RM-E5038、RM-E5039、RC-B4001、RM-B5005、RC-E3021F、RC-E3022F、RC-E8020S、RM-E8020S、RC-B8002S、RM-E1008、RC-E5040F、RM-E5040F、RC-E8006S、RM-E8006S、RC-D3003、RC-E8021、RM-E8021。，产品技术要求变更，仅作信息采集。

生产地址：

佛山市南海区狮山镇小塘工业大道五星段82号万洋创智园5栋

型号规格：

RC-D0001、RC-D0002、RC-D0003、RC-D0004、RC-E0001、RC-E0002、RC-E0003、RC-E0004、RC-E0005、RC-E0006、RC-E0007、RC-L0001、RM-E0001、RC-D1001、RC-D1002、RC-D1003、RC-D1004、RC-D1005、RC-D1006、RC-D1007、RC-D1008、RC-E1001、RC-E1002、RC-E1003、RC-E1004、RC-E1005、RC-E1006、RC-E1007、RC-E1008F、RC-E1009F、RC-E1010S、RC-L1001、RM-E1001F、RM-E1002、RC-D2001、RC-D2002、RC-D3001、RC-D3002F、RC-E3001、RC-E3002F、RC-E3003F、RC-E3004F、RC-E3005F、RC-E3006F、RC-E3007F、RC-E3008F、RC-E3009F、RC-E3010F、RC-E3011F、RC-E3012F、RC-E3013F、RC-E3014F、RC-E3015F、RC-E3016F、RC-E3017F、RC-E3018F、RC-E3019、RM-E3001S、RM-E3002、RC-B4001F、RC-B4002、RC-D4001、RC-D4002、RC-D4003、RC-D4004、RC-D4005、RC-D4006、RC-D4007、RC-E4001、RC-E4002、RC-E4003、RC-E4004、RC-E4005、RC-E4006、RC-E4007、RC-E4008F、RC-E4009、RC-E4010F、RC-E4011F、RC-E4012、RC-E4013、RC-E4014F、RC-E4015F、RC-E4016、RC-E4017、RC-E4018F、RC-B5001S、RC-B5002、RC-B5003S、RC-B5004、RC-D5001、RC-D5002、RC-D5003、RC-D5004、RC-D5005、RC-D5006、RC-D5007、RC-D5008、RC-D5009、RC-D5010、RC-D5011、RC-D5012、RC-D5013、RC-D5014、RC-D5015、RC-D5016、RC-D5017、RC-D5018、RC-D5019、RC-D5020、RC-D5021、RC-D5022、RC-D5023、RC-D5024、RC-D5025、RC-D5026、RC-D5027、RC-D5028、RC-D5029、RC-D5030、RC-E5001、RC-E5002、RC-E5003、RC-E5004F、RC-E5005S、RC-E5006S、RC-E5007、RC-E5008、RC-E5009F、RC-E5010、RC-E5011F、RC-E5012S、RC-E5013、RC-E5014、RC-E5015、RC-E5016、RC-E5017、RC-E5018、RC-E5019、RC-E5020、RC-E5021F、RC-E5022、RC-E5023S、RC-E5024、RC-E5025S、RC-E5026S、RC-E5027、RC-E5028F、RC-E5029、RC-E5030、RC-E5031、RC-E5032、RC-E5033S、RC-E5034、RC-E5035、RC-E5036、RC-E5037、RC-E5038、RC-E5039、RC-L5001、RC-L5002、RC-L5003、RC-L5004、RC-L5005、RC-L5006、RM-B5001、RM-D5001、RM-E5002、RM-E5003、RM-E5007、RM-E5008、RM-E5010、RC-D6001、RC-D6002、RC-D6003、RC-D6004、RC-E6001、RC-E6002、RC-E6003、RC-L6001、RC-D7001、RC-B8001S、RC-D8001、RC-D8002、RC-E8001、RC-E8002、RC-E8003、RC-E8004S、RC-E8005、RC-E8006、RC-E8007、RC-E8008、RC-E8009、RC-E8010、RC-E8011S、RC-E8012、RC-E8013S、RC-E8014、RC-E8015、RC-E8016、RC-E8017、RC-E8018、RC-L8001、RC-L8002、RM-E8001、RM-E8003、RM-B5001S、RM-D0003、RM-D1001、RM-D1003、RM-D3002F、RM-D5010、RM-D5016、RM-D7001、RM-D8001、RM-E1003、RM-E1004、RM-E1005、RM-E3005F、RM-E3010F、RM-E3019、RM-E4003、RM-E4004、RM-E4013、RM-E4014F、RM-E5001、RM-E5004F、RM-E5005S、RM-E5006S、RM-E5009F、RM-E5011F、RM-E5012S、RM-E5013、RM-E5016、RM-E5020、RM-E5021F、RM-E5023S、RM-E5024、RM-E5025S、RM-E5026S、RM-E5027、RM-E5032、RM-E5033S、RM-L5001、RM-E8002、RM-E8005、RM-E8006、RM-E8011S、RM-E8012、RC-E1011F、RC-E3020F、RC-E4019、RM-E5036、RC-E0008、RM-E5038、RM-E5039、RC-B4001、RM-B5005、RC-E3021F、RC-E3022F、RC-E8020S、RM-E8020S、RC-B8002S、RM-E1008、RC-E5040F、RM-E5040F、RC-E8006S、RM-E8006S、RC-D3003、RC-E8021、RM-E8021。

备注：

变更情况：2026年02月04日，型号/规格变更为RC-D0001、RC-D0002、RC-D0003、RC-D0004、RC-E0001、RC-E0002、RC-E0003、RC-E0004、RC-E0005、RC-E0006、RC-E0007、RC-L0001、RM-E0001、RC-D1001、RC-D1002、RC-D1003、RC-D1004、RC-D1005、RC-D1006、RC-D1007、RC-D1008、RC-E1001、RC-E1002、RC-E1003、RC-E1004、RC-E1005、RC-E1006、RC-E1007、RC-E1008F、RC-E1009F、RC-E1010S、RC-L1001、RM-E1001F、RM-E1002、RC-D2001、RC-D2002、RC-D3001、RC-D3002F、RC-E3001、RC-E3002F、RC-E3003F、RC-E3004F、RC-E3005F、RC-E3006F、RC-E3007F、RC-E3008F、RC-E3009F、RC-E3010F、RC-E3011F、RC-E3012F、RC-E3013F、RC-E3014F、RC-E3015F、RC-E3016F、RC-E3017F、RC-E3018F、RC-E3019、RM-E3001S、RM-E3002、RC-B4001F、RC-B4002、RC-D4001、RC-D4002、RC-D4003、RC-D4004、RC-D4005、RC-D4006、RC-D4007、RC-E4001、RC-E4002、RC-E4003、RC-E4004、RC-E4005、RC-E4006、RC-E4007、RC-E4008F、RC-E4009、RC-E4010F、RC-E4011F、RC-E4012、RC-E4013、RC-E4014F、RC-E4015F、RC-E4016、RC-E4017、RC-E4018F、RC-B5001S、RC-B5002、RC-B5003S、RC-B5004、RC-D5001、RC-D5002、RC-D5003、RC-D5004、RC-D5005、RC-D5006、RC-D5007、RC-D5008、RC-D5009、RC-D5010、RC-D5011、RC-D5012、RC-D5013、RC-D5014、RC-D5015、RC-D5016、RC-D5017、RC-D5018、RC-D5019、RC-D5020、RC-D5021、RC-D5022、RC-D5023、RC-D5024、RC-D5025、RC-D5026、RC-D5027、RC-D5028、RC-D5029、RC-D5030、RC-E5001、RC-E5002、RC-E5003、RC-E5004F、RC-E5005S、RC-E5006S、RC-E5007、RC-E5008、RC-E5009F、RC-E5010、RC-E5011F、RC-E5012S、RC-E5013、RC-E5014、RC-E5015、RC-E5016、RC-E5017、RC-E5018、RC-E5019、RC-E5020、RC-E5021F、RC-E5022、RC-E5023S、RC-E5024、RC-E5025S、RC-E5026S、RC-E5027、RC-E5028F、RC-E5029、RC-E5030、RC-E5031、RC-E5032、RC-E5033S、RC-E5034、RC-E5035、RC-E5036、RC-E5037、RC-E5038、RC-E5039、RC-L5001、RC-L5002、RC-L5003、RC-L5004、RC-L5005、RC-L5006、RM-B5001、RM-D5001、RM-E5002、RM-E5003、RM-E5007、RM-E5008、RM-E5010、RC-D6001、RC-D6002、RC-D6003、RC-D6004、RC-E6001、RC-E6002、RC-E6003、RC-L6001、RC-D7001、RC-B8001S、RC-D8001、RC-D8002、RC-E8001、RC-E8002、RC-E8003、RC-E8004S、RC-E8005、RC-E8006、RC-E8007、RC-E8008、RC-E8009、RC-E8010、RC-E8011S、RC-E8012、RC-E8013S、RC-E8014、RC-E8015、RC-E8016、RC-E8017、RC-E8018、RC-L8001、RC-L8002、RM-E8001、RM-E8003、RM-B5001S、RM-D0003、RM-D1001、RM-D1003、RM-D3002F、RM-D5010、RM-D5016、RM-D7001、RM-D8001、RM-E1003、RM-E1004、RM-E1005、RM-E3005F、RM-E3010F、RM-E3019、RM-E4003、RM-E4004、RM-E4013、RM-E4014F、RM-E5001、RM-E5004F、RM-E5005S、RM-E5006S、RM-E5009F、RM-E5011F、RM-E5012S、RM-E5013、RM-E5016、RM-E5020、RM-E5021F、RM-E5023S、RM-E5024、RM-E5025S、RM-E5026S、RM-E5027、RM-E5032、RM-E5033S、RM-L5001、RM-E8002、RM-E8005、RM-E8006、RM-E8011S、RM-E8012、RC-E1011F、RC-E3020F、RC-E4019、RM-E5036、RC-E0008、RM-E5038、RM-E5039、RC-B4001、RM-B5005、RC-E3021F、RC-E3022F、RC-E8020S、RM-E8020S、RC-B8002S、RM-E1008、RC-E5040F、RM-E5040F、RC-E8006S、RM-E8006S、RC-D3003、RC-E8021、RM-E8021。，产品技术要求变更，仅作信息采集。