CE Certificate Des Drug-Eluting Coronary Stent System

• Feature: Disposable, Disposable
• Certification: CE, FDA, ISO13485, CE, FDA, ISO13485
• Group: Adult
• Type: PCI
• Material: Niti
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Model NO.: DES
• Quality Guarantee Period: Two Years
• Logo Printing: Without Logo Printing
• Drug: Sirolimus
• Coating Thickness: 4.0+/-1.0um
• Coated Drug Concentration: 2.2ug/mm2
• Transport Package: Box, Al Bag, Pouch
• Specification: Diameter from 2.0mm to 5.0mm
• Trademark: OEM, Global
• Origin: Suzhou China
• Production Capacity: 20000/Year

Product Description

Company Profile



Kossel Medtech (Suzhou) Co., Ltd. established in 2013, has developed into a leading vascular intervention enterprise with comprehensive production and R&D capabilities. Manufacturing and R&D products include medical devices of the intervention  category of coronary, peripheral vessel, electrophysiology.
The total facility is more than 5,000 square meters. We have around 200 employees and 44% of them with bachelor degrees.
We have advanced equipment, well organized management, refined production technology, professional R&D and QC team.
Kossel was certified as National High-tech Enterprise in 2016, and passed ISO9001, ISO13485 quality management system and GMP certification.

Our Mission: Develop superb Medical Device for people's health and benefits.
Our Vision: Innovation for systematic clinical solutions, and a world-wide intervention leader.
Our Values: Be Pragmatic, Efficient, Collaborative, Willing to share,Hard Working and Dedication.

OEM/ODM services:

1. Laser cutting (316L/ L605/304T/ Nitinol/MP35N etc.)
2. Heat treatment
3. Electrochemical polishing
4. Stents griping

Stent Size Matrix


 

L/mm D/mm

8

12

13

15

16

18

20

21

23

24

28

29

33

38

40

2.0

√

√

√

√

√

√

√

√

√

√

-

-

-

-

-

2.25

√

√

√

√

√

√

√

√

√

√

-

-

-

-

-

2.5

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

2.75

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

3.0

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

3.5

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

4.0

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

4.5

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

5.0

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

ISO 9001 13485 Certificate





Production Line