FDA Registration
Active
🇰🇷 South Korea
NON-WOVEN CALF SLEEVE (DS021, DS022, DS023, DS024)
Reg #: 3033511104
·
FEI: 3033511104
·
Expires 2025
Products
1
Proprietary Names
8
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
- K203016
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 |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2021-03-29 |
Proprietary Names
NON-WOVEN CALF SLEEVE (DS021, DS022, DS023, DS024)
SOFT CALF SLEEVE (DS221, DS222, DS223, DS224)
DVT-2600
NON-WOVEN BOOT SLEEVE (DS041)
NON-WOVEN THIGH SLEEVE (DS011, DS012, DS013, DS014)
SOFT THIGH SLEEVE (DS211, DS212, DS213, DS214)
FOOT SLEEVE (DS031, DS033)
TUBING (DS300, DS301, DS302)
Establishment Types
Manufacture Medical Device