Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009134882

FEI Number

3009134882

Entity Name

DMED

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

Innovation Tower, 111, Sagimakgol-ro, Jungwon-gu, Seongnam-si Gyeonggi 13202, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dmed (Owner Number: 10037526)

Owner / Operator Contact Address

Innovation Tower, 111, Sagimakgol-ro, Jungwon-gu,, Seongnam-si, KR-41 13202, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 TR-PAD 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 Nasalvo 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2011-07-22
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2011-07-22
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2011-07-22
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2011-07-22
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2011-07-22
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2011-07-22
KAQ	Gouge, Nasal, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-07-22
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2011-07-22
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-07-22
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-10-12
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2023-09-11
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2011-07-22
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2011-07-22
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2011-07-22

Official Correspondent

Tae Hoon Koo

US Agent Details

Glen Koo Business: K resource Corp Email: glenkoo@hotmail.com Phone: (917) 5361538

Related Public Records

Same Entity

Dmed

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

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1057425	SOUTHEASTERN TECHNOLOGY dba Autocam Medical	Murfreesboro, TN, US
8044098	HGR INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
9680519	SUBAN Instruments Hungary Co.	DEBRECEN Hajdu-Bihar, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009134882. Last updated year: 2026. Please use registration number 3009134882 when referencing this establishment in official correspondence.