FDA Registration
Active
🇰🇷 South Korea
MagiCath II
Reg #: 3009758019
·
FEI: 3009758019
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WOOYOUNG MEDICAL CO LTD
- Registration Number
- 3009758019
- FEI Number
- 3009758019
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 98, Sangsin 2-gil, Jincheon-eup
- City
- Jincheon-gun Chungbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K210929
Owner / Operator
- Firm Name
- WOO YOUNG MEDICAL CO LTD
- Operator Number
- 10086818
- Address
- 98, Sangsin 2-gil, Jincheon-eup
- City
- Jincheon-gun
- State
- Chungbuk
- Postal Code
- 27846
- Country
- KR
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St. Suite 610
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-12-14 |
Proprietary Names
MagiCath II
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device