Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030970103

FEI Number

3030970103

Entity Name

AP MDS CO.,LTD.

City/State/Country

Incheon, KR

Establishment Address

5F, 39-36, Nonhyeon-ro 46beon-gil, Namdong-gu, Incheon 21655, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AP MDS Co.,Ltd. (Owner Number: 10083007)

Owner / Operator Contact Address

5F, 39-36, Nonhyeon-ro 46beon-gil, Namdong-gu, Incheon, KR-28 21655, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201776

PMA Number

N/A

All Registered Proprietary Names

Silicone Bandage Two-way and Three-way Disposable Silicone Foley catheters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-04-10
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2021-10-20

Official Correspondent

Jong Jeong Kim

US Agent Details

Won Lee Business: YTS Global Inc Email: Wonlee@Ytsglobal.Com Phone: (703) 3408178

Related Public Records

Same Entity

AP MDS 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030970103. Last updated year: 2026. Please use registration number 3030970103 when referencing this establishment in official correspondence.