KAWA MEDITECH ENTERPRISE INC.
is a Japan based manufacturer, wide range of medical and surgical devices with hi-technology & automation, labor control, a great potential for development, ISO9002, ISO13485-2003 QUALITY MANAGEMENT SYSTEM. The Company is part of the KAWA GROUP Holding. With branches in Japan, Hongkong, Singapore, USA and plant in PRC: Weifang KAWA Medical Products Co., Ltd.

The Company"s main aim is to develop, produce and sell disposable medical supplies which are of GMP/QSR, ISO, CE and FDA regulated, made from USP class VI materials so as to provide the most value to our customers, foster growth for our employees and suppliers, and strive for excellence in customer service and satisfaction.

CAPABILITY

MANUFACTURING FACILITY:

Total land area: 350,000 sq. Ft.
Total manufacturing facility: 150,000 sq. Ft.
Class 100,000 Cleanroom: 50,000 sq. Ft.
Injection molding machines: 40
Extrusion machines:10
In-house ETO gas sterilizers.
In-house blister packaging machines, access to the latest packing technologies available, several different packaging options such as pouch packaging(poly pouch or paper & film pouch), blister packaging and bulk packaging
Strict quality control testing. including sterility, toxicity, pyrogenicity, etc.
Cleanroom A/C---Climate&filtration control system.
PVC compounding & mixing system.

Manufacturing capability:.
IV Infusion set:. 150,000 sets per shift, 300,000 sets per day, 9 million sets per month
Burette infusion set:. 50,000 sets per shift, 100,000 sets per day, 3 million sets per month
Blood transfusion set:. 50,000 sets per shift, 100,000 sets per day, 3 million sets per month
[b]Syringe: 600,000 pcs per shift, 1.2 million pics per day, 36 million pcs per month
Scalp vein set: 150,000 pcs per shift, 300,000 pcs per day, 9 million pcs per month
Surgical Latex glove: 100,000 pairs per shift, 200,000 pairs per day, 6 million pairs per month
Orthopedics Intruments: according the order

CLEANROOM

8000 square meters class 100,000 cleanroom meet ISO13485-2003 and GMP standard, designed by our US senior engineer.

OEM Business and Contract Manufacturing
※　CAD Design and Molds in house making
※　New product development from concept to design to prototyping to mass production
※　Resolve your existing products problems
※　Improve your existing products by reducing cost and improving quality
※　FEA analysis and computer modeling of flow over implant, stress and heat transfer etc.

]

INJECTION MOLDING
Regular Machine Calibration Program
Preventative Maintenance Program
Computerized Production and Process Monitoring System
Temperature Controlled +/- 2 Degrees
Lighting Level of 100 F/C Through The Molding Area
Capability Analysis On Key Process Parameters

Quality Assurance:
Kawa"s quality assurance system encompasses a comprehensive and exhaustive series of physical, chemical and biological & microbiological tests and inspection at different stages in the production cycle. Beginning with constant surveillance and auditing of raw materials and its suppliers; intensive in-process control of all manufactured components & sub-assemblies to the final inspection & testing of the finished products. The systems are well documented and the adherences to quality norms meticulous. KAWA　has successfully implemented a quality management system and has been accredited by SGS Yarsley International Certification Services, United Kingdom and TUV, Germany for CE and ISO9002, ISO 13485-2003, GMP certificate from China FDA.

Our QC and QA technicians are well-trained employee by TUV Germany. Pre-inspection, In-process inspection and final inspection are well done during daily manufacturing process.

BIOLOGICAL TEST 　　　　　　　　　　　　 IN PROCESS INSPECTION