FDA Registration
Active
🇰🇷 South Korea
NON-WOVEN CALF SLEEVE (DS021, DS022, DS023, DS024)
Reg #: 3004116008
·
FEI: 3004116008
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DAESUNG MAREF CO.,LTD
- Registration Number
- 3004116008
- FEI Number
- 3004116008
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 298-24, Gongdan-Ro, Gunpo-si, Gyeonggi-do, 15809, KOREA
- City
- Gunpo-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 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 |
|---|---|---|---|---|---|
| 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
Develop Specifications But Do Not Manufacture At This Facility