FDA Registration
Active
🇰🇷 South Korea
DAESUNG MAREF CO.,LTD
Reg #: 3033511104
·
FEI: 3033511104
·
Expires 2026
Products
5
Proprietary Names
74
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DAESUNG MAREF CO.,LTD
- Registration Number
- 3033511104
- FEI Number
- 3033511104
- Status
- Active
- Expiry Year
- 2026
- 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
- K203353
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 |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2019-03-18 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2021-04-22 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2019-04-03 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2023-08-08 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2019-02-12 |
Proprietary Names
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)
DVT-PRO
EXTENSION PAD
TUBING
MULTI-USE CALF SLEEVE
FOOT SLEEVE
CALF SLEEVE
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)
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)
LF900
EXT.ZIPPER (4ELGL02, 4ELGX01, 4ELGY00, 4EAGF02)
ARM SLEEVE (M402, L402, 4AAGF3A)
LEG SLEEVE (4LAGL5A, 4LAGX40, 4LAGY00, S401, SW401, SXW401, M401, MW401, MXW401, L401, LW401, M403, MW403)
DVT-2600
LF-400
LEG sleeve
Arm sleeve
LX9max
Center body sleeve
SP-1000 (White)
CENTER BODY Sleeve (4SAGF5A)
LEG Sleeve (4LAGL5A, 4LAGX40, 4LAGY00)
SP-1000 (Black)
ARM Sleeve (4AAGF3A)
SP-2000 (Black)
SP-2000 (White)
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)
Establishment Types
Manufacture Medical Device