Medical Device Division · registration 210484ActiveDRGEM
Hong KongRadiographic Systems, DigitalClass IIIDRGEM Corporation
Official record identity
- MDACS listing number
- 210484
- Model name
- FDR Smart FGXR-EC20S, FDR Smart FGXR-EC25S, FDR Smart FGXR-EC32S, FDR Smart FGXR-EC40S, FDR Smart FGXR-EC50S
- Registration date
- March 11, 2026
- Expiry date
- January 16, 2032
- 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, Digital
Additional source fields
- AMD nomenclature code
- 18430
- 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
- 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.