Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004102812

FEI Number

3004102812

Entity Name

ADWIN KOREA CORP.

City/State/Country

Gangnam-gu Seoul, KR

Establishment Address

223, Yeoksam-ro, Gangnam-gu Seoul 06224, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADWIN KOREA CORPORATION (Owner Number: 9083346)

Owner / Operator Contact Address

223, Yeoksam-ro, Gangnam-gu, KR-11 06224, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

purederm clear spot patches Cold & Warm Pain Relief Patch Baby Teeth Wipes Nasal Strips Finger Teeth Wipes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-10-23
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2007-08-08
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2006-02-23
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2008-09-01
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2007-06-04

Official Correspondent

No official correspondent registered.

US Agent Details

UJU Krallum Business: ONBIX CORP US Email: onbixus@gmail.com Phone: (843) 5828036

Related Public Records

Same Entity

ADWIN KOREA CORPORATION

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3016445778	LABNPEOPLE	Yangju-si Gyeonggi, KR
3033273018	RASHENDZ, INC.	St Petersburg, FL, US
3008656870	DALIAN ORIENTECH CO.,LTD	Dalian Liaoning, CN
1629057	WINFIELD LABORATORIES, INC.	Richardson, TX, US
3021695082	BEONE CO., LTD.	Gimpo Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004102812. Last updated year: 2026. Please use registration number 3004102812 when referencing this establishment in official correspondence.