Medical Device Division · registration 140295ActiveGE
Hong KongRadiographic/Fluoroscopic Systems, Angiography/InterventionalClass IIIGE Hualun Medical Systems Co. Ltd.
Official record identity
- MDACS listing number
- 140295
- Model name
- Optima IGS 320
- Registration date
- July 08, 2024
- Expiry date
- August 25, 2029
- Source update date
- July 24, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
- Published category
- Radiographic/Fluoroscopic Systems, Angiography/Interventional
Official value: III
Published parties
- Registrant / registration holder
- GE Medical Systems Hong Kong Limited
- Manufacturer
- GE Hualun Medical Systems Co. Ltd.
Official description
Radiographic/Fluoroscopic Systems, Angiography/Interventional
Additional source fields
- AMD nomenclature code
- 16597
- Local responsible person phone
- 21006300
- Published manufacturer address
- No. 1, Yong Chang North Road, Beijing Economic Technological Development Zone, Beijing 100176, 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.