Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089808

FEI Number

3030089808

Entity Name

REOLITE COMPANY INC.

City/State/Country

Seoul, KR

Establishment Address

2F 39, Bomun-ro, Seongbuk-gu, Seoul 02873, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

REOLITE COMPANY Inc. (Owner Number: 10089412)

Owner / Operator Contact Address

2F 39, Bomun-ro, Seongbuk-gu, Seoul, KR-11 02873, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CLOLITE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	2023-12-05

Official Correspondent

Young Jin Lee

US Agent Details

JINA KIM Business: JK BIOSCIENCE INC. Email: jkim@jkbioscience.com Phone: (213) 2926474

Related Public Records

Same Entity

REOLITE COMPANY Inc.

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 3030089808. Last updated year: 2026. Please use registration number 3030089808 when referencing this establishment in official correspondence.