FDA Registration
Active
🇰🇷 South Korea
SEAWON MEDITECH CO., LTD.
Reg #: 3008770707
·
FEI: 3008770707
·
Expires 2026
Products
9
Proprietary Names
43
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SEAWON MEDITECH CO., LTD.
- Registration Number
- 3008770707
- FEI Number
- 3008770707
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 33, Bucheon-ro 298beon-gil, Wonmi-gu
- City
- Bucheon-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- Seawon Meditech Co., Ltd.
- Operator Number
- 10034631
- Address
- 33, Bucheon-ro 298beon-gil, Wonmi-gu
- City
- Bucheon-si
- State
- Gyeonggi
- Postal Code
- 14487
- Country
- KR
- Correspondent
- Chang Yong Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2010-12-17 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2023-09-14 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2010-12-17 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2010-12-17 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2010-12-17 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2010-12-17 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2019-08-27 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2010-12-17 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-02-12 |
Proprietary Names
Blue Pecker Plus (SWVP-13H11A)
SPASY (SWVP-13A)
JOIMAX (JMSWSNT)
Blue Pecker Plus (SWVP-11H11A)
Blue Pecker Plus (SWVP-13H11)
SPASY (SWVP-11S)
SPASY (SWMVP)
SPASY (SWVP-11A)
JOIMAX (JMSWSNT23)
JOIMAX (JMSWSNT20)
JOIMAX (JMSWSNS)
Blue Pecker Plus (SWVP-11H11)
MIXMAX (SWMX-CMS-01)
MIXMAX (SWMX-CMS-02)
JOIMAX (JMSWM-1)
SPASY (SWM-1)
JOIMAX (JMSWM-2)
JOIMAX (JMSWM-2T)
SPASY (SWM-2)
JOIMAX (JMSWM-5)
SPASY (SWDG-4A)
JOIMAX (JMSWM-4)
JOIMAX (CS6601-07)
SPASY (SWM-4)
JOIMAX (JMSWVEAS)
JOIMAX (JMPP0130BF)
SPASY (SWM-3)
JOIMAX (JMSWM-3)
COLEX (SWBMN15N15)
COLEX (SWBMN08N15)
COLEX (SWBMN11N15)
COLEX (SWBMN15H11)
COLEX (SWBMN15H15)
COLEX (SWBMN15N11)
COLEX (SWBMN11H11)
COLEX (SWBMN13H11)
COLEX (SWBMN11H15)
COLEX (SWBMN11N11)
SPASY (BCD Kit_SWM-KIT-T4-1)
SPASY (BCD Kit_SWM-KIT-T4)
SPASY (BCD Kit_SWM-KIT-T4-2)
JOIMAX (BCD Kit)
JOIMAX (JMSPASY-BI)
Establishment Types
Manufacture Medical Device