Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017644086

FEI Number

3017644086

Entity Name

GENESYSTEM CO., LTD.

City/State/Country

Daejeon, KR

Establishment Address

200-9, Techno2-ro, Yuseong-gu, Daejeon, Republic of Korea, Daejeon 34028, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Genesystem Co., Ltd. (Owner Number: 10078631)

Owner / Operator Contact Address

200-9, Techno2-ro, Yuseong-gu, Daejeon, Republic of Korea, Daejeon, KR-30 34028, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GENECHECKER® UF-300 Real-time PCR System WizDx F-150 Real-time PCR System GENECHECKER® UF-340 Real-time PCR System GENECHECKER® UF-400 All-In-One PCR System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-10-29

Official Correspondent

Rayna Jung

US Agent Details

Heuiyeon Kang Email: hykang9190@gmail.com Phone: (920) 6024666

Related Public Records

Same Entity

Genesystem 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 3017644086. Last updated year: 2026. Please use registration number 3017644086 when referencing this establishment in official correspondence.