Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018077452

FEI Number

3018077452

Entity Name

GL CO.,LTD

City/State/Country

Paju-si Gyeonggi, KR

Establishment Address

266, Heyri-ro, Tanhyeon-myeon, Paju-si Gyeonggi 10858, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GL Co.,LTD (Owner Number: 10080584)

Owner / Operator Contact Address

266, Heyri-ro, Tanhyeon-myeon, Paju-si, KR-41 10858, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HEATING PATCH FOR MENSTRUAL CRAMPS WITH EXTRA COVERAGE HEATING PATCH FOR MENSTRUAL CRAMPS Heat Haven Menstrual Heat Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2021-02-10

Official Correspondent

Jongmog Kim

US Agent Details

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

Related Public Records

Same Entity

GL 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

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3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018077452. Last updated year: 2026. Please use registration number 3018077452 when referencing this establishment in official correspondence.