Data / Medical devices / Taiwan / Carilex Medical, Inc.

Carilex Medical, Inc.: FDA-registered device maker in Guishan District Taoyuan, Taiwan, 5 510(k) clearances

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

Carilex Medical, Inc. is registered with the FDA (registration 9710603) in Guishan District Taoyuan, Taiwan. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Carilex Medical, Inc.

FDA registration number: 9710603
FEI number: 3003513125
Address: No. 77, Keji 1st Rd., Guishan District Taoyuan, Taiwan, 333
Owner or operator: Carilex Medical, Inc. (9048086)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: October 11, 2001
Registered through: 2026
Brand names listed: AVA Cure, AVA LAL, AVACare 2, Airrapy Blower, Bairrapy Mattress, Cari Chair, Centrius, Dual and more

Devices it lists

Device	Product code	Class	Role	Source
Bed, Flotation Therapy, Powered	IOQ	2	Manufacturer	accessdata.fda.gov
Bed, Patient Rotation, Powered	IKZ	2	Manufacturer	accessdata.fda.gov
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	LLI	2	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Cushion, Flotation	KIC	1	Manufacturer	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	Contract manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Exporter to the US	accessdata.fda.gov
Lift, Patient, Ac-Powered	FNG	2	Contract manufacturer	accessdata.fda.gov
Mattress, Air Flotation, Alternating Pressure	FNM	2	Manufacturer	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Manufacturer	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Exporter to the US, Foreign private label distributor, 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
April 17, 2024	K231646	Carilex VT¿200-i NX	OMP	Substantially Equivalent	Carilex Medical, Inc.	accessdata.fda.gov
December 15, 2021	K202823	Innomed NPWT Silicone Foam Dressing	OMP	Substantially Equivalent	Zhejiang Longterm Medical Technology Co., Ltd.	accessdata.fda.gov
August 9, 2018	K173407	VT - 100, VT - 200	OMP	Substantially Equivalent	Carilex Medical, Inc.	accessdata.fda.gov
June 8, 2018	K172725	VT Dressing Kits	OMP	Substantially Equivalent	Carilex Medical, Inc.	accessdata.fda.gov
October 13, 2016	K161410	VT·One, VT·One 60days	OMP	Substantially Equivalent	Carilex Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2024. 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.