FDA Registration
Active
🇰🇷 South Korea
Depth Gauge
Reg #: 3013271380
·
FEI: 3013271380
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEWON MEDIX, INC.
- Registration Number
- 3013271380
- FEI Number
- 3013271380
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- Sewon Medix, Inc.
- Operator Number
- 10053110
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46946
- Country
- KR
- Correspondent
- Jinsoo Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2016-11-08 |
Proprietary Names
Depth Gauge
SCREW DRIVER FOR MACHINE(MHD128S, MHD128M, MHD128L, MSD120S, MSD120M, MSD120L, MIHD20S, MIHD20, MIHD20L)
SCREW DRIVER FOR RATCHET(RHD128S, RHD128M, RHD128L, RSD120S, RSD120M, RSD120L, RIHD20S, RIHD20, RIHD20L)
DRILL STOPPER(DS507, DS508, DS510, DS511, DS513, DS515, DS607, DS608, DS610, DS611, DS613, DS615)
PARALLEL PIN(SPP40, SPP45, SPP50, SPP55, SPP60, SPP65)
FIXTURE DRIVER FOR RATCHET(IHRFD21S, IHRFD21L, IHRFD25S, IHRFD25L)
SCREW DRIVER FOR RATCHET(RHD120S, RHD120M, RHD120L, RHD123S, RHD123M, RHD123L, RHD125S, RHD125M, RHD125L)
DRIVER CONNECTOR(DCS100, DCM120)
FIXTURE DRIVER FOR MACHINE(IHMFD21S, IHMFD21L, IHMFD25S, IHMFD25L)
RATCHET WRENCH(SRW, SRW400)
HAND DRIVER(SDH128S, SDH128M, SDH128L, SDHS120S, SDHS120M, SDHS120L)
TORQUE WRENCH(STW30B, STW30BS, STW50B, STW50BS, STW80B, STW80BS)
HAND DRIVER(SDH120S, SDH120M, SDH120L, SDH123S, SDH123M, SDH123L, SDH125S, SDH125M, SDH125L)
MOUNT DRIVER(FMDMS, FMDMM, FMDML, FMDRS, FMDRM, FMDRL)
SOLID DRIVER(IHSD40, IHSD45, IHSD50, IHSD55, IHSD60, IHSD65)
SCREW DRIVER FOR MACHINE(MHD120S, MHD120M, MHD120L, MHD123S, MHD123M, MHD123L, MHD125S, MHD125M, MHD125L)
OPEN WRENCH(OW700)
DEPTH GAUGE(SDG)
TORQUE WRENCH(STW30S, STW30SS, STW50S, STW50SS, STW80S, STW80SS)
FIXTURE DIRVER FOR MACHINE (IHMFD25RS, IHMFD525RL, SGMFD21, SGMFD25R, SGMFD25)
GUIDE REAMER (SGRE52)
FIXTURE DIRVER FOR RATCHET (IHRFD25RS, IHRFD525RL, SGRFD21, SGRFD25R, SGRFD25)
Establishment Types
Manufacture Medical Device