Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029835065

FEI Number

3029835065

Entity Name

CELEMICS, INC.

City/State/Country

Seoul, KR

Establishment Address

Gasan digital 1-ro 131, Seoul 08506, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Celemics, Inc. (Owner Number: 10094282)

Owner / Operator Contact Address

Gasan digital 1-ro 131, Seoul, KR-11 08506, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Celemics EP Kit Celemics Whole Exome Panel Celemics LP Kit Celemics TE Kit CLM Polymerase

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-11-21

Official Correspondent

Hyoki Kim

US Agent Details

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

Related Public Records

Same Entity

Celemics, 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 3029835065. Last updated year: 2026. Please use registration number 3029835065 when referencing this establishment in official correspondence.