FDA Registration
Active
🇰🇷 South Korea
Top Fine®
Reg #: 3003589279
·
FEI: 3003589279
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDEXEL CO., LTD.
- Registration Number
- 3003589279
- FEI Number
- 3003589279
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 252, GeumgwangOsan-Ro, Geumgwang-myeon
- City
- Anseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K152410
Owner / Operator
- Firm Name
- MEDEXEL CO., LTD.
- Operator Number
- 9047850
- Address
- 252, GeumgwangOsan-Ro, Geumgwang-myeon
- City
- Anseong-si
- State
- Gyeonggi
- Postal Code
- 17535
- Country
- KR
- Correspondent
- Hee Nam KIM
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-02-15 |
Proprietary Names
Top Fine®
UltiCare®
Sure Comfort
Establishment Types
Manufacture Medical Device