Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022787

FEI Number

6425

Entity Name

Y.M.K. INTERNATIONAL CO., LTD.

City/State/Country

TAIPEI New Taipei, TW

Establishment Address

8F.,NO. 28, CHENGGONG RD., SEC. 4, NEIHU, TAIPEI New Taipei 11459, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Y.M.K. INTERNATIONAL CO., LTD. (Owner Number: 8022787)

Owner / Operator Contact Address

8F.,NO. 28, CHENGGONG RD., SEC. 4, NEIHU, TAIPEI, TW-NOTA 11459, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forceps Forceps, Medical, Disposable Needle Holder Scissors, General, Surgical Hemostat, Surgical YMK Int'l Skin staple remover, medical Scissors, Medical, Disposable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2011-08-01
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1987-01-15
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2011-08-01
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-10-18
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2011-08-01
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2016-05-04
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2000-07-10
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1987-01-15

Official Correspondent

JEFF KUNG

US Agent Details

Aizaz Akram Business: FINE SURGICAL INSTRUMENTS INC. Email: aizaz@finesurgical.com Phone: (516) 2927400

Related Public Records

Same Entity

Y.M.K. INTERNATIONAL 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Similar Registrations

Registration Number	Establishment Name	Location
3016544015	ARCULANT, INC.	Santa Clara, CA, US
1055890	PRINCETON MEDICAL GROUP, INC.	Franklin, TN, US
3004371426	Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, DE
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3003675041	SURGICAL INSTRUMENTS BELGIUM SA	GEMBLOUX Namur, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022787. Last updated year: 2026. Please use registration number 8022787 when referencing this establishment in official correspondence.