Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010611944

FEI Number

3010611944

Entity Name

CORE BIOTECH CO., LTD.

City/State/Country

Gwangju, KR

Establishment Address

2F 207ho, B-dong,313, Cheomdangwagi-ro, Buk-gu, Gwangju 61008, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Core Biotech Co., Ltd. (Owner Number: 10045601)

Owner / Operator Contact Address

2F 207ho, B-dong,313, Cheomdangwagi-ro, Buk-gu, Gwangju, KR-NOTA 61008, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Max-Prep Mono-Prep

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2013-12-06

Official Correspondent

Jong Min Kim

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225265

Related Public Records

Same Entity

Core Biotech Co., Ltd.

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

View Entity Profile →

Similar Registrations

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3003639866	RUSHABH INSTRUMENTS, LLC	Ivyland, PA, US
3018771894	Q-LINE BIOTECH LIMITED	Lucknow Uttar Pradesh, IN
3009034535	CELLSOLUTIONS LLC	Greensboro, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010611944. Last updated year: 2026. Please use registration number 3010611944 when referencing this establishment in official correspondence.