REMEX-GR100
Remedi Co., Ltd. · Dental
Open FDA's page for this record- Third party flag
- N
- City
- Seoul
- Advisory committee description
- Dental
- Address 1
- 69-14, Sakju-Ro 145beon-Gil
- Address 2
- Chuncheon-Si, Gangwon-Do
- Statement or summary
- Statement
- Product code
- EHD
- Zip code
- 24232
- Applicant
- Remedi Co., Ltd.
- Decision date
- 2024-05-13
- Decision code
- SESE
- Country code
- KR
- Device name
- REMEX-GR100
- Advisory committee
- DE
- Contact
- Sungho Cho
- K number
- K240759
- Date received
- 2024-03-20
- Review advisory committee
- RA
- Postal code
- 24232
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Unit, X-Ray, Extraoral With Timer
- Medical specialty description
- Dental
- Regulation number
- 872.1800
- Device class
- 2
- Registration number
- 1523530, 1526534, 3015376465, 9615832, 3016875543, 3012187973, 3004884150, 3005581016, 3012649815, 3005172103, 2424472, 3004706313, 8043962, 3015153900, 8044167, 3008361230, 3013099020, 9614977, 3006610845, 3008252267, 1226003, 3010446656, 3005246977, 2024949, 3006540014, 3009608361, 1423662, 8030876, 3011491794, 3002994636, 1054713, 3002819275, 3016075921, 3003528079, 3045816948, 1419489, 3003934980, 3022107311, 3013511605, 3031886796 +22 more
- FEI number
- 1523530, 1526534, 3003719498, 3015376465, 3004884150, 3016875543, 3012187973, 3003026827, 3005581016, 3012649815, 3005172103, 3004706313, 3015153900, 3002088145, 3008361230, 3013099020, 7695, 3006610845, 3002522649, 3008252267, 3002948158, 3010446656, 3000215273, 3005246977, 1000114111, 3006540014, 3009608361, 2024949, 3002772487, 3011491794, 3002994636, 3004084693, 3002819275, 3016075921, 3002808310, 3003528079, 3045816948, 1419489, 3003934980, 3022107311 +22 more