Qualification

Quality Commitment

Thoroughly tempered Med-Linket Quality——Super performance, high tolerance

设计能力 (2)

Med-Linket in shenzhen and shaoguan has a total area of more than 7000 square meters of manufacturing plants. In 2007, set up the industry’s first 100000 clean workshop level set of line and has their first molding tool workshop and wire workshop, give the maximum to meet customer production requirements.

For 13 years, Med-Linket in cable design, thread management, advanced tube extrusion, braid and shaft design and deep expertise in existing mature components product portfolio, to develop suitable for disposable or reusable complete cable assembly for customer, and can be completed in the company 2 class 100,000 clean room manufacturing.

From concept to production period, Med-Linket is committed to developing high-performance cables and sensors,and has a unique position in this area.With the ability of manufacturing complete equipment and advanced components within the enterprise, it can simplify the supply chain of customers and provide engineering expertise, manufacturing support, functional testing and measurement services.We have an advanced quality system designed to easily adapt to the needs of customers’ medical devices.

 

Each of Med-Linket product are required to undergo a international standards rigorous testing before Shipment.

IMG_8271改

2005—Med-Linket has passed ISO13485:2003 of TUV Approval;From 2006 to 2009,Compatible SpO2 sensor,Disposable Electrosurgical Pencil and the Temperature Probe have passed CE Approval,products has enter into Europe market.For 2009,Reusable SpO2 sensor,ECG Cable and lead wires,IBP cable,temperature cable,blood oxygen extension cable etc have passed FDA Approval.2015—Med-linket obtained the Anvisa Certification from Brazil Health Administration.In 2016, obtained the Japanese FMA medical device production license, the product entered the Japanese market.Med-Linket has been inherited and adhering to quality innovation, Passed the quality assessment conducted by the top patient monitor companies, and the experience of assisting the top medical companies in bidding.

CE   FCC  FDA  CFDA  FMA  ANVISA  

TUV ISO13485:2003    ISO9001