Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016075971

FEI Number

3016075971

Entity Name

Plasmapp Co., Ltd.

City/State/Country

Asan-si Chungnam, KR

Establishment Address

2F, 161 Asanbaelli-ro 388beon-gil, Eumbong-myeon, Asan-si Chungnam 31408, KR

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Plasmapp Co., Ltd. (Owner Number: 10083074)

Owner / Operator Contact Address

BVC-111, 125, Gwahak-ro, Yuseong-gu, KR-30 34141, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223025

PMA Number

N/A

All Registered Proprietary Names

STERLINK mini Sterilizer with STERLOAD mini Cassette Tyvek® Roll with CI for STERLINK Sterilizer Terragene Bionova® SCBI (BT96); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Chemdye® (CD42 STERLINK plus sterilizer with STERPACK plus cassette STERLINK plus Sterilizer with STERLOAD Cassette Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42) Tyvek® Roll with CI for STERLINK Sterilizer Tyvek® Roll with CI for STERLINK Sterilizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-04-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-04-16
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2023-04-16
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2023-04-16
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2021-10-23
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-10-23
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2023-05-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-05-16
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2023-05-16
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2023-06-01
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2023-06-01
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-06-01
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-06-01
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-05-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-05-16

Official Correspondent

Youbong Lim

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Plasmapp Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0043-2014	Advanced Sterilization Products	2	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014	Advanced Sterilization Products	2	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016075971. Last updated year: 2026. Please use registration number 3016075971 when referencing this establishment in official correspondence.