Medical Device Division · registration 200397ActiveDRGEM
Hong KongRadiographic SystemsClass IIIDRGEM Corporation
Official record identity
- MDACS listing number
- 200397
- Model name
- FDR Smart X (FDR Smart FGXR-C40S, FDR Smart FGXR-82S)
- Registration date
- August 07, 2025
- Expiry date
- November 18, 2030
- Source update date
- June 05, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- FUJIFILM Hong Kong Limited
- Manufacturer
- DRGEM Corporation
Official description
Radiographic Systems
Additional source fields
- AMD nomenclature code
- 18429
- Traditional Chinese local responsible person
- 富士膠片香港有限公司
- Local responsible person phone
- 23760998
- Published manufacturer address
- 7Fl, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro, Gwangmyeong-si, Gyeonggido, 14322, Korea (Republic of Korea)
- 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.