https://www.avient.com/news/polyone-launches-neu-view-technology-radiopaque-translucent-catheters
They are available in certified USP Class VI and ISO 10993 compositions.
Media contact
Michelle Maniscalco
Marketing Communications Manager, North America
Global Media Relations Manager
PolyOne Corporation
+1 440-930-1988
michelle.maniscalco@avient.com
https://www.avient.com/news/avient-launches-medical-tpe-grades-formulated-without-animal-derivatives
All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.
Michelle Maniscalco
Senior Manager, Marketing Communications
Avient Corporation
+1 440-930-1988
michelle.maniscalco@avient.com
https://www.avient.com/sites/default/files/resources/19.2540_C%2520Colorant%2520Chromatics%25209001-2015%2520Certificate%2520EXP%25202021%25209-24-2018.pdf
Certificate of Registration 9001:2015 MSP
9001:2015–MSP-ANAB-US (2.0)
Page 1 of 2
Certificate of Registration
of Quality Management System
to ISO 9001:2015
The National Standards Authority of Ireland certifies that:
Colorant Chromatics Ab
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
has been assessed and deemed to comply with the
requirements of the above standard in respect of the scope of
operations given below:
The Design, Manufacture and Sales of
Fluoropolymer Color Concentrates and
Compounds
Additional sites covered under this multi-site certification are listed on the
Annex (File No. 19.2540/C)
Approved by:
Geraldine LarkinChief
Executive Officer
Approved by:
Lisa Greenleaf
Operations Manager
Registration Number: 19.2540/C
Certification Granted: May 15, 1997
Effective Date: Oct 20, 2018
Expiry Date: Oct 19, 2021
National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412
9001:2015–MSP-ANAB-US (2.0)
Page 2 of 2
Annex to Certificate Number: 19.2540/C
Scope of Registration:
The Design, Manufacture and Sales of Fluoropolymer Color
Concentrates and Compounds
Activity Location
Central Management Group,
Design, Manufacture
Colorant Chromatics
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
File No.: 19.2540/C
Headquarters, Sales, Distribution Colorant Chromatics Europe B.V.
Hastelweg 269 - 273
NL-5652 CV Eindhoven
The Netherlands
File No.: 19.2540/B
Sales, Distribution Colorant GmbH
Justus-Staudt-Strasse 1
Limburg-Offheim
Germany
65555
File No.: 19.2540/A
Design, Manufacture, Sales,
Distribution
Chromatics, Inc.
19 Francis J.
https://www.avient.com/sites/default/files/2024-04/CCG Application Snapshot_Endoscope.pdf
Surgical instrument oem
SURGICAL
INSTRUMENT OEM
E N D O S C O P E C O M P O N E N T S
• Functional differentiation
• ISO 10993 compliance
• Excellent resistance to steam sterilization
• Excellent chemical resistance
• Delivered a variety of bright, distinguishing color
choices for functional differentiation
• Minimized color deviation
• Provided a biocompatible solution
• Offered low MOQ with flexible supply
Transcend Premier PPSU Healthcare Pre-
colored Solutions
KEY REQUIREMENTS
WHY AVIENT?
All Rights Reserved
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants
Slide 1: Surgical instrument oem
https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
MEDICAL DEVICE
MANUFACTURER
O S T O M Y B A G S E A L S
• Comply with ISO 10993 and FDA Class II medical device
regulations
• Offer Good sealing performance
• Provide technical supports for processing
recommendations
• Deliver a high compression set materials to improve
comfort
• Provided a medical-grade TPE to help the
customer meet necessary regulatory
specifications and gain market share
• Provided technical support during design
and the manufacturing process for EVA
bonding
• Delivered soft-touch feel and excellent
sealing performance
Versaflex HC Thermoplastic Elastomers -
G2705 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
Slide 1: MEDICAL Device manufacturer
https://www.avient.com/sites/default/files/2025-06/NEUSoft-Catheter-case study snapshot.pdf
MEDICAL DEVICE
MANUFACTURER
G U I D I N G C A T H E T E R
• Ultra-soft hardness of about Shore 50A
• Excellent extrusion performance, achieving a thickness of
about 0.1 mm
• Smooth surface
• Certification for biocompatibility
• Delivered an ultra-soft TPU that has good
elasticity, abrasion, and tear resistance
• Complied with ISO 10993 biocompatible
properties
• Offered onsite service to support rapid
extrusion performance for the customer
NEUSoft Thermoplastic Polyurethanes
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
Slide 1: Medical device Manufacturer
https://www.avient.com/products/long-fiber-technology
We have composite pellet manufacturing in North America and Europe guided by the ISO 9001:2015 certified quality system.
https://www.avient.com/company/sustainability/planet/alliances-partnerships
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/global-policy-anti-bribery-and-anti-corruption
Global ISO Certificate Library
https://www.avient.com/company
Global ISO Certificate Library