Flat-panel all-digital color ultrasound diagnostic system
- Device class
- Class II
- Model specifications
- Acclarix GX9 Acclarix GX9 Exp Acclarix GX9 Super Acclarix GX85 Acclarix GX86 Acclarix GX88 Acclarix GX89 Acclarix Acclarix GX6 Acclarix GX6 Exp Acclarix GX6 Super Acclarix GX55 Acclarix GX56 Acclarix GX58 Acclarix GX59 Acclarix acclarix GX9F Acclarix GX9 Pro Acclarix GX9 Adv Acclarix GX76 Acclarix GX78 Acclarix GX6F Acclarix GX6 Pro Acclarix GX6 Adv Acclarix GX9P Acclarix GX9 Plus Acclarix GX9 Ultra Acclarix GX6P Acclarix GX6 Plus Acclarix GX6 UltraAcclarix GX9、Acclarix GX9 Exp、Acclarix GX9 Super、Acclarix GX85、Acclarix GX86、Acclarix GX88、Acclarix GX89、Acclarix GX6、Acclarix GX6 Exp、Acclarix GX6 Super、Acclarix GX55、Acclarix GX56、Acclarix GX58、Acclarix GX59、Acclarix GX9F、Acclarix GX9 Pro、Acclarix GX9 Adv、Acclarix GX76、Acclarix GX78、Acclarix GX6F、Acclarix GX6 Pro、Acclarix GX6 Adv、Acclarix GX9P、Acclarix GX9 Plus、Acclarix GX9 Ultra、Acclarix GX6P、Acclarix GX6 Plus、Acclarix GX6 Ultra
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242061149
- Approval date
- August 29, 2024
- Expiry date
- August 28, 2029
- Name
- Edan Instruments, Inc.深圳市理邦精密仪器股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 15, Jinhui Road, Jinsha Community, Kengzi Street, Pingshan New District, Shenzhen深圳市坪山新区坑梓街道金沙社区金辉路15号
- Production address
- 深圳市坪山新区坑梓街道金沙社区金辉路15号
Suitable for clinical ultrasonography.
适用于临床超声检查。
仪器由主机与探头组成,可选配穿刺架、DICOM组件、ECG模块组件. 可选配探头型号为:C5-1Q、C5-1XQ、C5-2Q、C5-2XQ、C6-2XQ、L12-4HQ、L12-4BQ、L17-7HQ、L18-4XQ、P5-1Q、P5-1XQ、E10-3BQ、E10-3HQ、C6-2MQ. 可选配穿刺架型号为:BGK-002、BGK-003、BGK-005、BGK-006、BGK-007、BGK-009、BGK-027、BGK-P5-1X.
仪器由主机与探头组成，可选配穿刺架、DICOM组件、ECG模块组件。 可选配探头型号为：C5-1Q、C5-1XQ、C5-2Q、C5-2XQ、C6-2XQ、L12-4HQ、L12-4BQ、L17-7HQ、L18-4XQ、P5-1Q、P5-1XQ、E10-3BQ、E10-3HQ、C6-2MQ。 可选配穿刺架型号为：BGK-002、BGK-003、BGK-005、BGK-006、BGK-007、BGK-009、BGK-027、BGK-P5-1X。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Flat-panel all-digital color ultrasound diagnostic system in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242061149 and owned by Edan Instruments, Inc.. The device was approved on August 29, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.