FDA Registration
Active
🇰🇷 South Korea
ARM SLEEVE (M402, L402, 4AAGF3A)
Reg #: 3033511104
·
FEI: 3033511104
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DAESUNG MAREF CO.,LTD
- Registration Number
- 3033511104
- FEI Number
- 3033511104
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 32-33, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do,Republic of Korea
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K231437
Owner / Operator
- Firm Name
- DAESUNG MAREF CO.,LTD
- Operator Number
- 10023845
- Address
- 298-24, Gongdan-ro, Gunpo-si, Gyeonggi-do, 15809, Korea
- City
- Gunpo-si
- State
- Gyeonggi
- Postal Code
- 15809
- Country
- KR
US Agent
- Business Name
- MTECH GROUP
- Contact Name
- DAVE KIM
- Address
- 7505 Fannin St Suite 610, Houston Texas 77054 United States
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2023-08-08 |
Proprietary Names
ARM SLEEVE (M402, L402, 4AAGF3A)
EXT.ZIPPER (4ELGL02, 4ELGX01, 4ELGY00, 4EAGF02)
TUBING
LEG SLEEVE (4LAGL5A, 4LAGX40, 4LAGY00, S401, SW401, SXW401, M401, MW401, MXW401, L401, LW401, M403, MW403)
LF900
Establishment Types
Manufacture Medical Device