Medical Device Division · registration 200102ActiveGE Medical Systems (China)
Hong KongScanning Systems, Ultrasonic, General-PurposeClass IIGE Medical Systems (China) Co., Ltd.
Official record identity
- MDACS listing number
- 200102
- Model name
- Versana Balance (H48352BP, H48352BT, H48352BR, H48492BZ, H48352BS, H48492BY, H48492BT), Probes (4C-RS, L6-12-RS, 3Sc-RS, 8C-RS, E8C-RS, E8Cs-RS, 6S-RS, 12L-RS, LK760-RS, 12S-RS, L8-18i-RS, RAB2-6-RS)
- Registration date
- June 26, 2025
- Expiry date
- May 25, 2030
- Source update date
- August 26, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- GE Medical Systems Hong Kong Limited
- Manufacturer
- GE Medical Systems (China) Co., Ltd.
Official description
Scanning Systems, Ultrasonic, General-Purpose
Additional source fields
- AMD nomenclature code
- 15976
- Local responsible person phone
- 21006300
- Published manufacturer address
- No. 19, Changjiang Road, Wuxi National Hi-Tech Dev.Zone, 214028 Jiangsu, China
- Revision number
- b
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.