Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015375647

FEI Number

3015375647

Entity Name

RAEL KOREA CO., LTD.

City/State/Country

Seoul, KR

Establishment Address

446 Bongeunsa-ro, Spigen HQ Building A, Seoul 06153, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Rael Korea Co., Ltd. (Owner Number: 10061090)

Owner / Operator Contact Address

446 Bongeunsa-ro, Spigen HQ Building A, Seoul, KR-11 06153, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rael Organic Cotton Reusable Pads for Bladder Leaks (Slim, Medium, Large, Overnight) Rael Beauty Miracle Patch Invisible Spot Cover Rael Beauty Miracle Patch Spot Control Cover Rael Miracle Patch XL Spot control cover Rael Miracle Patch Overnight Spot Cover Rael MIRACLE PATCH DUO Invisible Spot Cover + Spot Control Cover Advanced Strength Retinol Spot Cover Pad - Petite Liner - Long Pad - Regular Pad - Overnight Liner - Regular Pad - Large Rael Ultra Secure Period Underwear (L-XL) Rael Ultra Secure Period Underwear (S-M) Rael Organic Cotton Cover Panty Liners Extra Long Rael Beauty Miracle Patch Microcrystal Spot Cover Rael Miracle Patch Dark spot Cover 6ct

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2019-08-22
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2019-09-04
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2019-08-22
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-09-04

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc. Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Rael Korea 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
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

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3011446173	FISCHER MANUFACTURING LLC	Fairfield, OH, US
3010048541	ABENA NORTH AMERICA, INC.	Oceanside, CA, US
3016452317	GUANGDONG CHUANTIAN SANITARY PRODUCTS CO.,LTD	Zhongshan Guangdong, CN
3012162353	INTELLIGENT FABRIC TECHNOLOGIES (NORTH AMERICA) INC.	Markham Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015375647. Last updated year: 2026. Please use registration number 3015375647 when referencing this establishment in official correspondence.