SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.
| Packaging Details | Aseptic package / Double package / Vacuum package |
| Payment Terms | T/T |
| Delivery Time | According to contract request |
| Supply Ability | According to products feature |
| name | Medical Device Assembly |
| type | Metal micro cutting parts 4 - 5mm |
| brand | JENITEK |
| application | Medical biopsy forceps |
| Brand Name | OEM |
| Place of Origin | China |
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Product Specification
| Packaging Details | Aseptic package / Double package / Vacuum package | Payment Terms | T/T |
| Delivery Time | According to contract request | Supply Ability | According to products feature |
| name | Medical Device Assembly | type | Metal micro cutting parts 4 - 5mm |
| brand | JENITEK | application | Medical biopsy forceps |
| Brand Name | OEM | Place of Origin | China |
| High Light | medical equipment assembly ，medical assembly line | ||
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
Suzhou Jenitek currently manufactures products for interventional and implantable devices. and includes a Class 100,000 Clean Room, with capabilities up to class 10,000, and certified Class 100 Laminar Flow Hoods. Our implement processing is to use special post-processing technology and non-contact measuring methods to inspect them.
As a contract manufacturer, you benefit from dealing with Jenitek and can be confident of excellence at every stage of product development.
Regular audits and factory inspections by CSA ensure our quality system operates at the level of performance required to consistently produce high quality Often times our micro machined parts reach the smallest limit and we hold tolerances to meet customer requirement.
And our manufacturing process applies strict controls to deliver quality products on schedule.
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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