Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710603

FEI Number

3003513125

Entity Name

Carilex Medical, Inc.

City/State/Country

Guishan District Taoyuan, TW

Establishment Address

No. 77, Keji 1st Rd., Guishan District Taoyuan 333, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Carilex Medical, Inc. (Owner Number: 9048086)

Owner / Operator Contact Address

No. 77, Keji 1st Rd., Guishan Townshiip, TW-TAO 333, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

S1001-6130 Canister for VT 100 - 500ml lock NX S1004-6010 Canister for VT One 150ml S1001-6100 Canister for VT 100 - 300ml luer lock S1001-6110 Canister for VT 100 - 500ml luer lock S1001-6140 Canister for VT 100 - 1000ml lock NX S1004-6030 Canister for VT One - 150ml Luer Lock S1001-6060 Canister for VT 100 300ml lock S1001-6040 Canister for VT 100 1000ml lock S1001-6020 Canister for VT 100 500ml lock S1001-6120 Canister for VT 100 - 300ml lock NX S1001-2150 VT Drape and Port Set Kit L Lock S1001-2200 VT Dressing Kit TS S Carilex S1001-2040 VT Dressing Kit S Carilex S1001-2220 VT Dressing Kit TS L Carilex S1001-8300 VT Drape 2pcs pack S1001-8200 VT 100 Y Connector S1001-2180 VT Dressing Kit NX L Carilex S1001-2130 VT Drape and Port Set Kit S Lock S1001-8160 VT Port Set Kit S1001-2160 VT Dressing Kit NX S Carilex S1001-8190 VT Instill Port Set Kit S1001-2050 VT Dressing Kit M Carilex S1001-8180 VT Dressing Universal Adaptor S1001-2170 VT Dressing Kit NX M Carilex S1001-2120 VT Dressing Kit XL Carilex S1001-8220 VT NX Port Set Kit S1001-2190 VT Dressing Kit NX XL Carilex S1001-2060 VT Dressing Kit L Carilex S1001-2100 VT Spiral Dressing Kit Black Lock S1001-2210 VT Dressing Kit TS M Carilex S1001-2140 VT Drape and Port Set Kit M Lock S1002-3062 VT 200-i NX PU Global Carilex S1002-3022 VT 200-i PU Global Carilex S1002-3052 VT 200 NX PU Global Carilex S1002-0062 VT 200-i NX SYS Global Carilex S1002-0022 VT 200-i SYS Global Carilex S1002-0052 VT 200 NX SYS Global Carilex S1001-0033 VT 100 SYS Global Lock Carilex S1001-3033 VT 100 PU Global Lock Carilex S1002-3012 VT 200 PU Global Carilex S1002-0012 VT 200 SYS Global Carilex TheraFlo 9 Mattress TheraFlo 7 Mattress TheraFlo AVA LAL TheraFlo AP 9 Airrapy Blower DualFlex ePhysio10-12 AVA Cure S2304-3022 CozinyPlus P.U. Global Carilex Centrius Entrina FIT Mattress Envelop S2302-2010 Coziny 100 M-set 41 x 70cm DTX Carilex LUX Mattress AVA Activity Analytics Entrix NX S2302-2020 Coziny 200 M-set 49 x 75cm DTX Carilex Dual S2302-2030 Coziny 300 M-set 70 x 140cm DTX Carilex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2018-12-11
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2011-10-27
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-06-10
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2024-04-19
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-09-05
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2017-06-23
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2014-09-12
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2017-06-23
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2001-10-11

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants Inc Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Carilex Medical, Inc.

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
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

Similar Registrations

Registration Number	Establishment Name	Location
3010300504	SERRES OY	Kauhajoki as Pirkanmaa, FI
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3019794450	KIEN AN TRANSPOWER COMPANY LIMITED	HO CHI MINH CITY Tay Ninh, VN
3043165985	CHAFON TECHNOLOGY CO., LIMITED	TSIM SHA TSUI Hong Kong, CN
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710603. Last updated year: 2026. Please use registration number 9710603 when referencing this establishment in official correspondence.