SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.
| Packaging Details | Aseptic package / Double package / Vacuum package |
| Delivery Time | According to contract request |
| Payment Terms | T/T |
| Supply Ability | According to products feature |
| name | medical components |
| material | Titanium,platinum,stainless steel, brass, plastics |
| OEM zccept | Yes |
| Place of Origin | CHINA |
| Brand Name | OEM |
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Product Specification
| Packaging Details | Aseptic package / Double package / Vacuum package | Delivery Time | According to contract request |
| Payment Terms | T/T | Supply Ability | According to products feature |
| name | medical components | material | Titanium,platinum,stainless steel, brass, plastics |
| OEM zccept | Yes | Place of Origin | CHINA |
| Brand Name | OEM | ||
| High Light | medical device parts ，medical equipment parts | ||
Precious metal tube device converted into medical components
Quick Details:
| Material: | Titanium,platinum,stainless steel, brass, plastics, |
processing range: |
According to customer’s request |
| Function: | For medical |
| Certificate : | ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001 |
Description
The guide pipe consists of a handle/stress buffer and a guide pipe rod. The pipe is divided into three layers: inner layer, middle layer and outer layer. The outer layer of the catheter is mainly Arnitel (polymerase ester), the middle layer is tungsten wire/stainless steel wire, and the inner layer is polytetrafluoroethylene. The product is sterilized with ethylene oxide and used once.
The catheter may provide access for the balloon to expand the catheter, guide wire or other medical equipment through the catheter. This device should not be used in cerebral vessels. Peripheral catheters are intended for common blood vessels and peripheral blood vessels. Coronary catheters are intended for common blood vessels and coronary arteries.
Quality Assurance
Jenitek is committed to supplying products and services that meet the needs of customers, comply with statutory and regulatory requirements, increase customer satisfaction and maintain the effectiveness of the quality management systems through continuous improvement in products, processes and services.
Jenitek's quality management system has been certified ISO 13485:2012 and ISO 9001:2008 in order to fulfill each of our customers' specific requirements. FDA's QSR 21 CFR PART 820 and EU MDD 93/42 EEC certifications are in process.
We have a thorough quality system including four levels of documentation including manuals, procedures, work instructions and records. According to system documentation and processes, our quality activities such as production, inspection, product development (NPI), process validation, supplier chain control, and continuous improvement are controlled. This means we can deliver precision, performance and safety products and services to our customers around the world.
6 Sigma Quality Team The Jenitek quality team understands these system standards are not only the foundation of quality management but also paramount to the importance of our medical products, customers and product development, production, and improvement process. We have extensive experience with quality management and use a range of methods and tools, including IQ/OQ/PQ, FMEA, PFMEA, and Design of Experiments (DoE) to support in product development and improvement processes.
Packing and Tracing
Products with validated sterile packing. Sealer and testing equipment specifically configured to meet stringent packing validation requirements.
Certificaton
| · ISO 9001:2008 | Certified |
| · ISO 13485:2012 | Certified |
| · ISO 14001:2004 | Certified |
| · OHSAS 18001 | Certified |
| · FDA 21CFR 820 | In-Process |
| · EU MDD 93/43 | In-Process |
| · ISO 14971 2004 | Compliance |
Company Details
Business Type:
Manufacturer,Distributor/Wholesaler,Importer,Exporter,Seller,Other
Year Established:
2010
Employee Number:
100~120
Ecer Certification：
Active Member
Jenitek established in 2010, it is located in Medical Device Industrial Park of Suzhou New District and is a professional contract manufacturer for medical devices. Based on our capability of assembling various types of micro-medical devices and processing parts and components, we provide ... Jenitek established in 2010, it is located in Medical Device Industrial Park of Suzhou New District and is a professional contract manufacturer for medical devices. Based on our capability of assembling various types of micro-medical devices and processing parts and components, we provide ...
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