Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007791595

FEI Number

3007791595

Entity Name

UNIMAX MEDICAL SYSTEMS INC.

City/State/Country

New Taipei City, TW

Establishment Address

8F-2, No. 127, Lane 235, Pao Chiao Rd, Xindian District, New Taipei City 231, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Unimax Medical Systems Inc. (Owner Number: 10028682)

Owner / Operator Contact Address

8F-2, No 127, Lane 235, Pao Chiao Rd, Xindian District, New Taipei City, TW-TPE 231, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103509

PMA Number

N/A

All Registered Proprietary Names

Wound Retractor Suction Liner Irrigation Pump Veress Needle Suction Irrigation Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2019-07-25
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2011-09-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-10-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-12-25
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2011-03-29
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2010-11-30
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-05-26
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2011-08-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2011-08-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-05-31

Official Correspondent

No official correspondent registered.

US Agent Details

Matthew Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Unimax Medical Systems Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015497424	UNIMAX MEDICAL SYSTEMS INC.	Yilan County, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
2027111	APPLIED MEDICAL RESOURCES CORP.	RSM, CA, US
3009051888	Applied Medical Distribution Center	Irvine, CA, US
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN
8030672	Cirpro de Delicias S. de R.L. de C.V.	DELICIAS Chihuahua, MX
3031757047	Solventum US LLC	Brookings, SD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007791595. Last updated year: 2026. Please use registration number 3007791595 when referencing this establishment in official correspondence.