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Provide Medical Device Consulting and Regulatory Requirements Compliance Services

for ISO 13485, CE Mark and FDA Compliance for Medical Devices.

A GMP specialist will full medical device manufacturing and quality management expertise.  

 

 YORK PRECISION TECHNOLOGY (YANGZHOU) CO., LTD. is a Singapore Sole Proprietary Invested Company with its Registered Capital of USD 1 million, and set up its Manufacturing Plant in Jiangsu Yangzhou, Gaoyou. Equipped with Class 100k dynamic clean room and state-of-art Technology, which Specialized in Tight Tolerance and Precision Manufacturing

 With Extensive Experience, in PVC, FEP, TPU, TPE, PU, PP, PE Medical used tubing and tight tolerance Replication Manufacturing Process, the Company is specialized in Health Care and Precision Manufacturing. With its Research & Design, Extrusion and Replication Capabilities, we offer pre-development, mass production services to customers.


Their core competencies include:
•Complex catheter and medical tube extrusions
•Precision micro-molded components

•Class 10k Dynamic cleanroom
•Class 100k Dynamic GMP certified cleanroom

•Controlled environment production office
•Total cleanroom area 600m2

Tubing Types and Operations:

  • I.V. Catheter Tubing production

•Single-Lumen
•Multi-Lumen
•Co-Extrusion
•Tip Forming
•Coiling
•Radiopaque Striping

•Material Selection
•Material Formulation
Materials:

•FEP
•Polyurethane
•Nylon
•PEBAX
•PEEK
•PVC
•Polyethylene

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993