Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011496777

FEI Number

3011496777

Entity Name

BIODYNE

City/State/Country

Seoul, KR

Establishment Address

24-4 Achasan-ro, 5-gil, Seongdong-gu, Seoul 04793, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biodyne (Owner Number: 10047880)

Owner / Operator Contact Address

24-4 Achasan-ro, 5-gil, Seongdong-gu, Seoul, KR-11 04793, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PATHPLORER Dilute Solution PATHPLORER Cervical Oral Solution PATHPLORER Urine-CSF Solution PATHPLORER Non-Gyn Lysis Solution PATHPLORER Gyn Lysis Solution PATHPLORER Urine Bottle PATHPLORER Body Fluid-FNA Solution PATHPLORER Respiratory Tract Solution Cellprep Membrane Filter PATHPLORER Membrane Filter Cellprep Coated Microscope Slide PATHPLORER Coated Microscope Slide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2014-11-12
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2014-11-12
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2014-11-12

Official Correspondent

Wookbin Im

US Agent Details

Won Woo Suh Business: HSchem America Email: mjk11@hotmail.com Phone: (213) 5597719

Related Public Records

Same Entity

Biodyne

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009034535	CELLSOLUTIONS LLC	Greensboro, NC, US
1419341	Leica Biosystems Richmond, Inc.	Richmond, IL, US
1221855	Hologic, Inc.	LONDONDERRY, NH, US
9710094	YD DIAGNOSTICS	Yongin-si Gyeonggi, KR
3006330030	Hologic, Inc.	Marlborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011496777. Last updated year: 2026. Please use registration number 3011496777 when referencing this establishment in official correspondence.