FDA Registration
Active
🇰🇷 South Korea
DMED
Reg #: 3009134882
·
FEI: 3009134882
·
Expires 2026
Products
19
Proprietary Names
79
Establishment Types
1
Classifications
19
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Registration Details
- Registration Name
- DMED
- Registration Number
- 3009134882
- FEI Number
- 3009134882
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Innovation Tower, 111, Sagimakgol-ro, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- Dmed
- Operator Number
- 10037526
- Address
- Innovation Tower, 111, Sagimakgol-ro, Jungwon-gu,
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13202
- Country
- KR
- Correspondent
- Tae Hoon Koo
US Agent
- Business Name
- K resource Corp
- Contact Name
- Glen Koo
- Address
- 1100 New Hwy
- City
- Farmingdale
- State
- NY
- ZIP
- 11735
- Country
- US
- [email protected]
- Phone
- 917 5361538
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2011-07-22 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2011-07-22 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2011-07-22 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2015-10-12 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2023-09-11 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2011-07-22 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2011-07-22 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2011-07-22 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2011-07-22 |
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 2020-02-01 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2011-07-22 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2011-07-22 |
Proprietary Names
Polytech Breast Implant Sizer
Polytech Breast Caliper
Polytech Breast Tape Measure
External penile rigidity
GBC Cathter U2500, U3000,U4000,U5000,U6000, D2500,D3000,D4000,D5000, P2000,3000,4000,5000,6000 Series
GBC Cathter 1500, 2000, 3000, 4000, 5000, 6000, 6500, 7000,7500,8000,8500,9000,9500,10000 Series
Radio Therapy Balloon Cathter -DA2500, 3000, 4000,5000
Radio Therapy Balloon Cathter -PA2000, PA3000,PA4000,PA5000
SBC( Balloon catheter)
Radio Therapy Balloon Cathter -GA1500,GA2000, GA3000, GA4000, GA5000, GA5500, GA6000, GA6500, GA7000 Series
RBC Cathter 4000,4500,5000,5500,6000,6500,7000,7500,8000,8500,9000,9500,10000 Series
Radio Therapy Balloon Cathter UA2500,UA 3000,UA 4000,UA5000
Sinus Balloon Catheter Kit
Sinus Balloon Catheter(W/Illumination)
Sinus Balloon Catheter
Sinus Balloon Catheter (with Guide)
Sinus Balloon Catheter(W/ Pressure)
Vinci, Signature, Mist,
Ghrenos
Kogel
Derma Guard
Laetigen
Opticon
(Polytech DE)
Meme
Replicon
Optimam
Nasalvo
Cure foam
Nasalvo-TR(Thrombin)
Nasalvo-Plus
Hemostop-PAD
Hemostop TR-PAD
Hemostop TR
Pore Gel
Colla-PAD
Pore Gel(NG)
Cure Foam
Hemostop PAD
Curve
Helix
Mini Sling Guide
Blood Vessel Membrane
Colla-PAD(Bio)
Surgilub
Mini-Sling
Cure Mesh
NS Cavity Splint
Cure Foam 5DS
NS soft Splint
Cure Foam 7DS
NS Hard Splint
Cure Foam 3DS
NS Flex Splint
Hemo Stop
Surgi Shield -NS, OS, ENT. GS, OB/Gyn, Uro
Colla Shield
Hemostop-TR(Thrombin)
Hyagen
Cure Shield
Curewel
Cure Guard
Pro-Shield
Juvencoll
Curewl Plus
Juvencoll Light
LaetiGen
Hyagen-CT
Sinus Balloon cathter -SBC4,6,8,
Spine Bone Cement Kit
RTBC-PA type
RTBC-DA type
RTBC
Radio Therapy Balloon Cathter
RTBC-UA type
RTBC-GA type
GBC
Easy fit
Sinus IRRIGATOR
Establishment Types
Manufacture Medical Device