Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030333982

FEI Number

3030333982

Entity Name

ART & DESIGN INTERNATIONAL CO., LTD.

City/State/Country

SEOUL, KR

Establishment Address

#1102, 166, Yeongsin-ro, Yeongdeungpo-gu, SEOUL 07251, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ART & DESIGN INTERNATIONAL CO., LTD. (Owner Number: 10094518)

Owner / Operator Contact Address

#1102, 166, Yeongsin-ro, Yeongdeungpo-gu, SEOUL, KR-11 07251, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

#OOTD STAR SPOT PATCH OOTD CAREDERMTHIN 2-STEP SPOT PATCH OOTD STAR SPOT PATCH #OOTD CAREDERMTHIN 2-STEP SPOT PATCH

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	2025-12-04

Official Correspondent

GYUSUB SHIN

US Agent Details

GYUSUB SHIN Business: ART & DESIGN INTERNATIONAL INC Email: admin@ootdbeauty.com Phone: (307) 2002803

Related Public Records

Same Entity

ART & DESIGN INTERNATIONAL CO., LTD.

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

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 3030333982. Last updated year: 2026. Please use registration number 3030333982 when referencing this establishment in official correspondence.