Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015497424

FEI Number

3015497424

Entity Name

UNIMAX MEDICAL SYSTEMS INC.

City/State/Country

Yilan County, TW

Establishment Address

No. 37, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County 26841, TW

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Insufflation Tubing Set Veress Needle Wound Retractor Smoke Evacuation Tubing Suction Liner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-12-25
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-07-13
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2011-08-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2011-08-25
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2010-08-16
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-05-26
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
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2009-10-02
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2011-03-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-06-12
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2019-11-11

Official Correspondent

Jim Hsieh

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
3007791595	UNIMAX MEDICAL SYSTEMS INC.	New Taipei City, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015497424. Last updated year: 2026. Please use registration number 3015497424 when referencing this establishment in official correspondence.