Development and manufacturing of medical devices for decubitus prevention and wound care, including anti-decubitus mattresses and NPWT systems
Carilex Medical Inc.
Taoyuan City (Guishan District), Taiwan · Elmshorn, Germany · Polegate, Great Britain · City of Industry, CA, USA · Castle Hill, Australia · Tokyo, JapanNew on Amplifa
About Carilex Medical
Carilex Medical is a medical device manufacturer headquartered in Taoyuan City, Taiwan, that has been developing and manufacturing systems for decubitus prevention and wound management for over thirty years. The product portfolio includes therapeutic support surfaces (Anti-Decubitus mattresses and coverlets), power control units for air mattress systems, and negative pressure wound therapy (NPWT) systems such as the VT•100, VT•200, and NPWT NX product lines. The company covers the entire value chain – from research and development through proprietary design and engineering to manufacturing, quality control, regulatory affairs, and OEM production. Founded in 1985, initially operating in the textile and apparel industry, the company transitioned to the medical device sector in 1991 and utilizes this manufacturing expertise for mattresses and support surfaces to this day. Since 2019, Carilex has been part of the Shuttle Group. The products are manufactured according to ISO 13485, possess several FDA 510(k) clearances, and are distributed in over 40 countries; target markets include acute and long-term care and homecare. In addition to its headquarters, Carilex maintains sales companies in Germany (Elmshorn), Great Britain, the USA, Australia, and Japan.
- Site
- Taoyuan City, Taiwan
- Processes
- OEM Manufacturing of Mattresses and Coverlets (mattresses and coverlets), Manufacturing of Medical Devices (Anti-Decubitus Mattresses, Therapeutic Support Surfaces), Design and Engineering of Medical Devices (in-house design and engineering to manufacturing), Manufacturing of Power Control Units (Control Systems for Air Mattresses), Research and Development, Manufacturing, Quality Control and Assurance, Regulatory Affairs
- Materials
- Textiles, Assembly of Biomedical Systems, Design and Engineering
- Certificates
- ISO 13485, FDA 510(k) Clearance, ANVISA Registration, ANVISA Registration (Brazil)
- Founded
- 1985
- Employees
- 51-200
- Industries
- Medical Technology, Wound Care / Wound Management, Decubitus Prevention, Negative Pressure Wound Therapy (NPWT), Acute and Long-Term Care, Homecare
- 01
Research and Development
- 02
Design and Engineering
- 03
Manufacturing (including OEM)
- 04
Quality Control and Assurance
- 05
Regulatory Affairs
- 06
Sales in over 40 Countries
Processes and Manufacturing Competencies
Textiles
Used since the OEM production of mattresses and coverlets for therapeutic support surfaces.
Assembly of Biomedical Systems
Manufacturing of anti-decubitus mattresses, power control units, and NPWT systems.
Design and Engineering
Internal development capabilities from design and engineering to manufacturing and sales.
Locations
Taoyuan City (Guishan District), Taiwan
TWHeadquarters with Manufacturing, Sales, and Quality Assurance
Elmshorn, Deutschland
DEEurope – Sales (Carilex Medical Technologies GmbH)
Polegate, East Sussex, Großbritannien
GBUK – Sales and Marketing (Carilex Medical Ltd.)
City of Industry, CA, USA
USAmericas – Sales (Carilex Medical USA, Inc.)
Castle Hill, NSW, Australien
AUANZ – Sales (KCare Healthcare Solutions Pty Ltd.)
Tokio, Japan
JPJapan – Support and Sales (Carilex Medical Japan)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| OEM Manufacturing of Mattresses and Coverlets (mattresses and coverlets)Assembly | – | – | – | – | Textile |
| Manufacturing of Medical Devices (Anti-Decubitus Mattresses, Therapeutic Support Surfaces)Assembly | – | – | – | – | – |
| Design and Engineering of Medical Devices (in-house design and engineering to manufacturing)Engineering | – | – | – | – | – |
| Manufacturing of Power Control Units (Control Systems for Air Mattresses)Assembly | – | – | – | – | – |
Additional services
Quality and Certifications
Carilex is certified according to ISO 13485 for medical device quality management systems. Several products hold FDA 510(k) clearances; additionally, there is an ANVISA registration in Brazil.
| Evidence | Taoyuan City (Guishan District) |
|---|---|
| ISO 13485 | |
| FDA 510(k) Clearance | |
| ANVISA Registration (Brazil) |
History
- 1985
Founding; original focus on textile and apparel industry
- 1991
Shift to the medical device industry; OEM manufacturing of mattresses and coverlets
- 1995
First Power Control Unit designed and manufactured; cooperation with ITRI Taiwan; Patent for Rotor Valve
- 1998
Establishment of the internal R&D team
- 2001
ISO 13485 Certification
- 2002
Introduction of I.P.S. Technology
- 2007
Patent and introduction of A.R.T. Technology; establishment of UK subsidiary
- 2010
Relocation of headquarters to Taoyuan, Taiwan; building with 120 employees
- 2012
Renaming of Suzric Enterprise to Carilex Medical
- 2014
Establishment of the NPWT product line VT•100
- 2016
FDA 510(k) Clearance for VT•ONE & VT•ONE 60 Days
- 2017
Start of VT•200 development
- 2018
FDA 510(k) Clearances for VT•100 and VT•200; launch of Centrius Pump
- 2019
Acquisition by Shuttle Inc. (Shuttle Group); launch of AVA Envelop & AVA LAL
- 2020
ANVISA Registration Brazil
- 2022
Launch of NPWT NX
- 2023
Launch of AVA ENVELOP IoT (IoT Air Mattress System)