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Flat-panel all-digital color ultrasound diagnostic system - NMPA Registration 粤械注准20242061149

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.

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NMPA Official Data
Class II
粤械注准20242061149
Flat-panel all-digital color ultrasound diagnostic system
平板式全数字彩色超声诊断系统
NMPA Registration Number: 粤械注准20242061149
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Intended Use
English

Suitable for clinical ultrasonography.

中文

适用于临床超声检查。

Device Classification
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 Ultra
Acclarix 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 Information
Registration Number
粤械注准20242061149
Approval Date
August 29, 2024
Expiry Date
August 28, 2029
Registrant
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 Facility
Production Address
深圳市坪山新区坑梓街道金沙社区金辉路15号
Structure and Composition
English

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.

中文

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。

Additional Information
Appendix
产品技术要求