| Production Environment: | 10000 Class Clean Workshop |
|---|---|
| Particle Pollutionss Test: | Less Than 90 |
| Initial Pollution Bacteria: | Less Than 100cfu |
| Shipment Documents: | Packing List, Inspection Report, Coc |
| Feature: | Disposable |
| Certification: | ISO13485 |
| Customization: |
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Suppliers with verified business licenses
Audited Supplier Nanos Biomaterial (Suzhou) Co., Ltd was founded in 2016, specializing in coronary interventional medical devices core parts. We also welcome OEM/ODM cooperation.
Our original PTFE coating technology and tube making technology came from Japan, and these technologies have been used in the field of medical devices for more than 30 years, and our team members are experienced field experts from China and Japan. Our total number of employees is about 100.
With consistent innovation abilities, advanced production capacity and 7,000 square meters of professional facilities and laboratories; we have obtained more than 50 intellectual property rights or patents, passed ISO 9001, ISO 13485 quality systems. Our products are used in dozens of countries and we have customers on every continent.
We devote ourselves to developing excellent products, strive to be an international leading enterprise in the intervention field and are fully committed to contributing to human well-being! 
Materials
1. Ground Wire=304V SS
2. Coated Tube=304L SS, PTFE coating
3. HUB material=Lexan HPS7
4. Strain Relief=98% pebax 6333SA01 plus 2% blue colorant
Each lot of material can be manufactured from multiple groups of raw material
Hypotube
5. No burrs are present at either end of the hypotube and lumen of the hypotube not to be blocked
6. No kinks or bends over the entire length
7. Hypotube straightness: Max deflection when rolled on a flat surface is ⩽0.040"
8. Outside surface to be free from pits, knicks, scratches or other visible damage with the unaided eye
9. Hypotube is clean, passivated to ASTM A967
10. Ultimate tensile strength of hypotube is 180±15kpsi
Luer and Strain Relief
11. Luer to hypotube bond withstand a minimum tensile force of 2.5lbf(11.12N)
12. Hub/Hypotube/Strain Relief assembly to have leak rate not greater than 0.05ATM/sec when tested at 28.5ATM with an AQL of 1.0, C=0
| Coating Length | ⩽1500mm |
| Thickness of PTFE coating | 6-13µm |
| Friction of PTFE coating | ⩽3.6N (average 2.8N) |
| Coating peeling resistance | 1.5-2.5N |
| Crossing profile | 668-696µm |
| Steel tube size | Reference specification sheet,or can be customized according to customer requirements |
| HUB design | Overmoulded, the shape of HUB can be customized according to customer requirements |
| Distal design | Spiral Cutting and Weld Wire Distal |
Our Exhibition
Our products are of great quality and with competitive price. And have been praised In the domestic and overseas.
1.What products do you offer?
We offer wide range of interventional medical device core parts, including Hypotube, Wire, Mandrel. and medical devices of OEM/ODM service, including PTCA, NC PTCA, CTO, PTA/HP PTA balloon catheter. We also provide medical raw materials and their machining parts.
2.What certificates do you obtain?
ISO 9001, ISO 13485, GMP certificates
3. What is your minimum order quantity (MOQ)?
500pcs for parts, 100pcs for devices
4.Are your products sterilized?
Yes, we can provide products after EO sterilized.
5.I'm a distributor and I need validate your products prior to distributing in my region. Would you send me free samples?
In most cases, we offer ten parts or one device sample for evaluation. Express fee will be paid by clients.
6.I am looking for components, such as tubes, wires or connectors. Can you offer me these?
Yes, we can provide components or raw materials.
7.What is your payment term?
EXW quotation, 100% T/T payment in advance.
8.How many countries are your products used?
We have customers all over the world.
Suppliers with verified business licenses
Audited Supplier 
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