Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014442295

FEI Number

3014442295

Entity Name

COIZ CO., LTD

City/State/Country

Seoul, KR

Establishment Address

37-4 Hwagok-ro 59-gil, Gangseo-gu, Seoul 07650, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COIZ CO., LTD (Owner Number: 10058843)

Owner / Operator Contact Address

37-4 Hwagok-ro 59-gil, Gangseo-gu, Seoul, KR-11 07650, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AstrodomeFacial O2 Plus AstrodomeFacial AllTune OXYCRYO HiFULDM HiFULDM Facial AllFit AstrodomeFacial AstrodomeFacial O2 Plus Oz Portable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-11-21
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-11-07
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2024-04-19

Official Correspondent

JEONGMIN LEE

US Agent Details

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

Related Public Records

Same Entity

COIZ CO., LTD

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014442295. Last updated year: 2026. Please use registration number 3014442295 when referencing this establishment in official correspondence.