Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020925311

FEI Number

3020925311

Entity Name

BIONEER CORPORATION

City/State/Country

Yuseong-gu Daejeon, KR

Establishment Address

Bioneer Global Center, 71, Techno 2-ro, Yuseong-gu Daejeon 34013, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIONEER CORPORATION (Owner Number: 10034490)

Owner / Operator Contact Address

Bioneer Global Center, 71, Techno 2-ro, Yuseong-gu, KR-30 34013, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Exicycler 96 Exicycler 384 Exicycler V5 96 Exicycler V5 384 Exicycler V5 384 Fast Exicycler V5 96 Fast ExiPrep Dx Mycobacteria Genomic DNA Kit ExiPrep Dx Viral RNA Kit MagListo 5M Viral DNA/RNA Extraction Kit ExiPrep48 Dx ExiPrep 48 Viral DNA/RNA Kit ExiPrep Dx Blood Genomic DNA Kit ExiPrep Dx Viral DNA Kit ExiPrep 48 Viral RNA Kit ExiPrep16 Dx ExiPrep Dx Bacteria Genomic DNA Kit ExiPrep Dx Viral DNA/RNA Kit ExiPrep96 Lite ExiPrep 96 Genomic DNA Kit ExiPrep 96 Viral DNA/RNA Kit Protonion 96 Viral RNA Kit

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	2020-06-12
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2010-12-06

Official Correspondent

Han-Oh Park

US Agent Details

EDGAR ELENES Email: Edgar.Elenes@bioneer.us.com Phone: (510) 2173318

Related Public Records

Same Entity

BIONEER CORPORATION

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 3020925311. Last updated year: 2026. Please use registration number 3020925311 when referencing this establishment in official correspondence.