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Unimax Medical Systems Inc.: FDA-registered device maker in Yilan County, Taiwan, 6 510(k) clearances

Name: Unimax Medical Systems Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Unimax Medical Systems Inc. is registered with the FDA (registration 3015497424) in Yilan County, Taiwan. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 20, 2011. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3015497424
Address: No. 37, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County, Taiwan, 26841
Owner or operator: Unimax Medical Systems Inc. (10028682)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: July 13, 2009
Registered through: 2027
Brand names listed: Insufflation Tubing Set, Irrigation Pump, Smoke Evacuation Tubing, Suction Irrigation Set, Suction Liner, Veress Needle, Wound Retractor, Yankauer suction probe

Devices it lists

Device	Product code	Class	Role	Source
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Pneumoperitoneum Needle	FHO	2	Manufacturer	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Manufacturer	accessdata.fda.gov
Tube, Smoke Removal, Endoscopic	FCZ	1	Manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 20, 2011	K103508	UNMIAX LAPAROSCOPIC INSTRUMENT	GEI	Substantially Equivalent	Unimax Medical Systems, Inc.	accessdata.fda.gov
October 17, 2011	K112358	UNIMAX TROCAR SYSTEM	GCJ	Substantially Equivalent	Unimax Medical Systems, Inc.	accessdata.fda.gov
September 9, 2011	K111622	UNIMAX ANTI-FOG SOLUTION	OCT	Substantially Equivalent	Unimax Medical Systems, Inc.	accessdata.fda.gov
August 19, 2011	K111441	UNIMAX VERESS NEEDLE	HIF	Substantially Equivalent	Unimax Medical Systems, Inc.	accessdata.fda.gov
May 19, 2011	K103509	UNIMAX SUCTION IRRIGATION SET	GCJ	Substantially Equivalent	Unimax Medical Systems, Inc.	accessdata.fda.gov
May 6, 2011	K103510	UNIMAX SPECIMEN RETRIEVAL SYSTEM	GCJ	Substantially Equivalent	Unimax Medical Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 20, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.