200397
Radiographic Systems
射线照相系统
DRGEM Corporation·III·Hong Kong MDACS·Registered November 19, 2020
Device overview
- Risk class
- III
- Product code
- 18429
- State
- current
- Status
- N/A
- Product code detail
- 18429 Radiographic Systems
Manufacturer (製造商)
- Name
- DRGEM CorporationDRGEM Corporation
- Country
- South Korea韩国
- Address
- 7Fl, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro, Gwangmyeong-si, Gyeonggido, 14322, Korea (Republic of Korea)7Fl, E-B/D 光明科技园, 60 Haan-ro, 光明市, 京畿道, 14322, 韩国(大韩民国)
Authorised representative (AR)
- Name
- FUJIFILM Hong Kong Limited富士胶片香港有限公司
- Phone
- 23760998
Regulatory timeline
- Registration date
- November 19, 2020
- Expiry date
- November 19, 2025
Product models
FDR Smart X (FDR Smart FGXR-C40S, FDR Smart FGXR-82S)
FDR Smart X (FDR Smart FGXR-C40S, FDR Smart FGXR-82S)
About this record
This profile provides complete Hong Kong MDACS registration information for Radiographic Systems. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Radiographic Systems
產品資訊： 射线照相系统