FDA Registration
Active
🇰🇷 South Korea
DAESUNG MAREF CO.,LTD
Reg #: 3004116008
·
FEI: 3004116008
·
Expires 2026
Products
5
Proprietary Names
74
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- DAESUNG MAREF CO.,LTD
- Registration Number
- 3004116008
- FEI Number
- 3004116008
- Status
- Active
- Expiry Year
- 2026
- 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
- K203417
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 Ste 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 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2021-07-04 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2019-03-18 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2019-02-12 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2019-04-03 |
Proprietary Names
SOFT THIGH SLEEVE (DS211, DS212, DS213, DS214)
DVT-4000S
SOFT CALF SLEEVE (DS221, DS222, DS223, DS224)
SOFT BOOT SLEEVE (DS241)
NON-WOVEN THIGH SLEEVE (DS011, DS012, DS013, DS014)
TUBING (DS300, DS301, DS302)
NON-WOVEN CALF SLEEVE (DS021, DS022, DS023, DS024)
SOFT FOOT SLEEVE (DS031, DS033)
LEG sleeve
Arm sleeve
LX9max
Center body sleeve
LF900
EXT.ZIPPER (4ELGL02, 4ELGX01, 4ELGY00, 4EAGF02)
TUBING
ARM SLEEVE (M402, L402, 4AAGF3A)
LEG SLEEVE (4LAGL5A, 4LAGX40, 4LAGY00, S401, SW401, SXW401, M401, MW401, MXW401, L401, LW401, M403, MW403)
DVT-PRO
EXTENSION PAD
MULTI-USE CALF SLEEVE
FOOT SLEEVE
CALF SLEEVE
DVT-2600
REUSABLE ANKLE WRAP (CTCAF00)
ONE PERSON USE UNIVERSAL WRAP[M](CTCUMD0)
REUSABLE SHOULDER WRAP(CTCSM00)
REUSABLE UNIVERSAL WRAP(CTCUL00)
ONE PERSON USE BACK WRAP[L](CTCBFD0)
ONE PERSON USE ELBOW WRAP(CTCEFD0)
CTC-7
ONE PERSON USE KNEE WRAP(CTCKFD0)
REUSABLE ELBOW WRAP(CTCEF00)
REUSABLE UNIVERSAL WRAP[L] (CTCUL00)
REUSABLE UNIVERSAL WRAP[M](CTCUM00)
ONE PERSON USE ANKLE WRAP(CTCAFD0)
REUSABLE KNEE WRAP(CTCKF00)
ONE PERSON USE SHOULDER WRAP(CTCSMD0)
Tubing (CTC7210)
ASSIST BAND (CTCAS00)
ONE PERSON USE UNIVERSAL WRAP[L](CTCULD0)
REUSABLE BACK WRAP (CTCBF00)
ONE PERSON USE HIP WRAP[LEFT](CTCHFL0)
ONE PERSON USE HIP WRAP[RIGHT](CTCHFR0)
ONE PERSON USE UNIVERSAL WRAP[XL](CTCUXD0)
Tubing(Glove) (1000910)
RL-500
REHA PEN (RL50210)
REHA GLOVE M(1HDGM30)
Detection HUB (RL5A210)
REHA GLOVE L(1HDGL30)
Remote switch (1000530)
Tubing(Finger,Wrist), COM cable(1000860)
SP-1000 (White)
CENTER BODY Sleeve (4SAGF5A)
LEG Sleeve (4LAGL5A, 4LAGX40, 4LAGY00)
SP-1000 (Black)
ARM Sleeve (4AAGF3A)
SP-2000 (Black)
SP-2000 (White)
LF-400
SILICONE BLADDER SINGLE CUFF (DTC-SA3443, DTC-SA2128, DTC-SA1228, DTC-SA4563)
DTS-3000
BLUE MAIN HOSE (1000190)
DOUBLE CUFF (DTC-D04, DTC-D05, DTC-D06, DTC-D07)
IOP Sensor (0100090)
CONE SINGLE CUFF (DTC-C25, DTC-C26, DTC-C27)
RED MAIN HOSE (1000180)
CONE DOUBLE CUFF (DTC-CD25, DTC-CD26, DTC-CD27)
SILICONE BLADDER SINGLE CUFF (DTC-SA01, DTC-SA02, DTC-SA05, DTC-SA06, DTC-SA07, DTC-SA15)
GRAY MAIN HOSE (1000200)
SINGLE CUFF (DTC-S02,DTC-S04,DTC-S05,DTC-S06, DTC-S07, DTC-S08)
SILICONE BLADDER CONE SINGLE CUFF (DTC-CS1843, DTC-CS2443, DTC-CS3043, DTC-CS3443, DTC-CS4443)
SILICONE BLADDER SINGLE CUFF (DTC-SA1243, DTC-SA1843, DTC-SA2443, DTC-SA3043)
SILICONE BLADDER CONE DOUBLE CUFF (DTC-CD1855, DTC-CD2455, DTC-CD3055, DTC-CD3455, DTC-CD4475)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device