https://www.avient.com/sites/default/files/2021-12/certificate-of-registration-avient-s.a-r.l.-sweden-filial-nov-29-2021.pdf
e-Certificate of registration Swedish Companies Registration Office BRANCH D1a- 6858922 Registration number Date of registration of the company Document created on Date of registration of current name Page 516411-5031 2018-08-28 2021-11-30 17:11 2021-11-29 1 (3) Pending matter(s) The register indicates pending matter(s) regarding a change to the registered information at the time this certificate was created. e-Certificate of registration Swedish Companies Registration Office BRANCH D1a- 6858922 Registration number Date of registration of the company Document created on Date of registration of current name Page 516411-5031 2018-08-28 2021-11-30 17:11 2021-11-29 2 (3) Registration number: 516411-5031 Business name: Avient S.à r.l., Sweden Filial Address: Drottninggatan 56 411 07 GÖTEBORG County and municipality: Västra Götaland, Göteborg Note: MANAGING DIRECTOR 630516 Palm, Christoph, Gruss Strooss 35, L-9991 WEISWAMPACH, LUXEMBURG AUDITORS 556053-5873 Ernst & Young Aktiebolag, Box 7850, 103 99 STOCKHOLM Represented by: 850807-5135 PRINCIPALLY RESPONSIBLE AUDITOR 850807-5135 Edman, Mikael Thomas Gunnar, c/o Ernst & Young AB, 401 82 GÖTEBORG SIGNATORY POWER Signatory power alone by Palm, Christoph FINANCIAL YEAR Registered financial year: 0101 - 1231 DATE OF REGISTRATION OF CURRENT AND PREVIOUS BUSINESS NAMES 2021-11-29 Avient S.à r.l., Sweden Filial 2018-08-28 PolyOne S.à.r.l., Sweden Filial INFORMATION ABOUT THE FOREIGN COMPANY B226205 Avient S.á.r.l. 19, Route de Bastogne L-9638 Pommerloch LUXEMBURG Registered office of the foreign company: Pommerloch Name of the register in which the foreign company is registered: e-Certificate of registration Swedish Companies Registration Office BRANCH D1a- 6858922 Registration number Date of registration of the company Document created on Date of registration of current name Page 516411-5031 2018-08-28 2021-11-30 17:11 2021-11-29 3 (3) RCS, Registre de Commerce, Luxembourg Business Register LUXEMBURG Foreign company's financial year: 0101 - 1231 The above information is an extract from the Trade and Industry Register Bolagsverket, the Swedish Companies Registration Office.
https://www.avient.com/sites/default/files/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION VEHICLE BATTERY MANUFACTURER C E L L P A C K C O O L I N G T U B E • Comply with ISO 3384-1:2011 for TPE compression set • Comply with ISO 11359-2:1999 standard for linear thermal expansion • Good ethanediol resistance • Good sealing performance • Customized a Shore 60A hardness TPE formulation with good physical property retention • Achieved good compression set and bonding performance with PA12 • Qualified thermal expansion by customer • Provided excellent ethanediol resistance under both low and high temperature conditions KEY REQUIREMENTS CHEMICAL RESISTANCE + SEALING LEARN MORE OnFlex™ TPE Custom Formulation Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2022-08/IATF 16949 North Baltimore.doc.pdf
Microsoft Word - IATF 16949 North Baltimore[80].doc ABS Quality Evaluations Certificate Of Conformance This is to certify that the Quality Management System of: Avient Corporation Engineered Materials Division Avient Corporation 733 E.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Page 1 of 2 ABS Quality Evaluations IATF 16949:2016 Certificate Of Conformance ANNEX Certificate No: IATF No: 38972 0422162 Avient Corporation Engineered Materials Division At Below Facilities: Facility: Corporate 33587 Walker Road Avon Lake, OH 44012 U.S.A.
https://www.avient.com/sites/default/files/resources/US_N%2520Baltimore_IATF%252016949_Exp%25209-2021.pdf
ECert.QECertificate Page 1 of 2 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 38972 Effective Date: 04 September 2018 Expiration Date: 03 September 2021 Issue Date: 31 December 2018 IATF No: 0328156 Alex Weisselberg, President DESIGN AND MANUFACTURE OF CUSTOM PVC PLASTISOL AND PVC SLUSH MOLD POWDER (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2021-04/iatf-16949-58976-lockport-17nov2020.pdf
ECert - 2020-11-17T151438.723.pdf Page 1 of 2 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 58976 Effective Date: 08 February 2019 Expiration Date: 09 August 2022 Revision Date: 17 November 2020 IATF No: 0349837 Dominic Townsend, President DESIGN AND MANUFACTURE OF THERMOPLASTIC COMPOUNDS (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations Avient Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/US_Norwalk_IATF16949_2020Exp.pdf
ECert.pdf Page 1 of 2 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 39913 Effective Date: 30 November 2017 Expiration Date: 29 November 2020 Issue Date: 30 November 2017 IATF No: 0280241 Alex Weisselberg, President DESIGN AND MANUFACTURE OF COLOR CONCENTRATES (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/Dyersburg%2520IATF%252016949-2016%2520exp%25208-13-2021.pdf
ECert.QECertificate Page 1 of 2 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 39032 Effective Date: 14 August 2018 Expiration Date: 13 August 2021 Issue Date: 17 August 2018 IATF No: 0322936 Alex Weisselberg, President MANUFACTURE, DESIGN AND SUPPLY OF PROPRIETARY THERMOPLASTIC COMPOUNDS, INCLUDING THE SUPPLY OF TOLL COMPOUNDING SERVICES (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2021-08/avient-cdp-climate-change-questionnaire-2021.pdf
In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide.
ISO 14001, Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of facilities.
In addition, Avient has ISO 9001 worldwide and ISO 14001 and ISO 50001 certification at many facilities.
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Dynaflex™ G2706 28A USP Class VI, ISO 10993, Food contact EtO Soft translucent grade, grippy feel Dynaflex™ G2711 43A USP Class VI, ISO 10993, Food contact EtO Highly colorable solution, grippy feel, low compression set Versaflex™ CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993, US Food contact EtO Clear boilable grades; ABS, PC bondable Versaflex™ G2705 N 60A USP Class VI, ISO 10993, Food contact EtO/Steam High resilience, low compression set Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear VERSAFLEX™ CL AND DYNAFLEX™ TPEs OVERMOLDING FOR ERGONOMICS • Adds good tactile surface with soft-touch feel • Available in a variety of color effects and textures • Improves grip, cushion, and comfort • Enhances functional performance like sealing properties, vibration damping, oxygen barrier, and scratch and abrasion resistance • Reduces assembly costs, good processability • Offers excellent adhesion to a wide range of substrates Applications: • Glucometers • Medical tools overmolds • Injector pens • Analysis devices VERSALLOY™ HC & VERSAFLEX™ HC TPEs SEALING & RESEALING • Rubbery feel and soft touch • No coring, good puncture, and resealability in static stoppers • Meets low coefficient of friction requirements in dynamic seals • Low extractables • Suitable to overmold onto polyolefins Applications: • Sealing and resealing septum • Seals and sanitary gaskets • Syringe plungers and tips MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versalloy™ HC 9210-45N 45A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9210-55N 55A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9210-70N 70A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9220-43N 43A USP Class VI, ISO 10993-4/5 EtO Extrusion grade, high temperature resistance Versaflex™ HC 2110-35N 34A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Resealing, elevated comp set Versaflex™ HC 2110-57B 57A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Low stiction VERSAFLEX™ CL AND DYNAFLEX™ TPEs HIGH CLARITY GRADES WITHOUT PLASTICIZERS • Water clear grades formulated without phthalate plasticizers • Meets medical regulatory USP Class VI and ISO 10993-4,5 • Food contact and FDA compliant • Autoclave and radiation stable • Low extractable • High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70 Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820 Flexural Strength (MPa) 80 90 104 86 68 68 Flexural Modulus (MPa) 2500 2700 2500 2300 1980 1590 HDT: 0.45, 1.8 (MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0 UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0 UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2 COMPETITIVE MATERIAL COMPARISON ENGINEERED POLYMER FORMULATIONS FOR HEALTHCARE TRILLIANT™ HC THERMOPLASTICS The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges of medical devices and equipment.
https://www.avient.com/sites/default/files/2022-05/MEVOPUR LQ for Silicone Elastomers_CN.pdf
可根据要求提供多种定制化 颜色解决方案 根据ISO 13485/GMP质量体系生产,并拥有变 更控制管理 原材料红外光谱分析和常规批次检测 根据ISO 10993第18部分对正己烷、异丙醇及 水中的可萃取性进行评估 • • • • 法规支持 原材料根据ISO 10993-1和USP第、 章(VI类)对原材料进行生物评估的预测试 向FDA提交所有标准颜色的DMF/MAF文件 • • 应用 医疗器械,如导管和连接器、注射器针头及无 针连接器 与皮肤接触设备,如可穿戴设备或医疗器械的 柔软触感表面 • • MEVOPUR LQ 配方可用于要求严苛的应用,包 括: MEVOPUR™-LQ 不透明红(PMS198C) 产品编号:FZ3M415008 MEVOPUR™-LQ 透明红 产品编号:FZ3M415009 MEVOPUR™-LQ 不透明蓝(PMS292C) 产品编号:FZ5M415008 MEVOPUR™-LQ 透明蓝 产品编号:FZ5M415009 MEVOPUR™-LQ 不透明黄(PMS1205C) 产品编号:FZ1M415005 MEVOPUR™-LQ 透明黄 产品编号:FZ1M415006 MEVOPUR™-LQ 不透明绿(PMS346C) 产品编号:FZ6M415008 MEVOPUR™-LQ 透明绿 产品编号:FZ6M415009 MEVOPUR™-LQ 不透明紫(PMS2655C) 产品编号:FZ4M415003 MEVOPUR™-LQ 透明紫 产品编号:FZ4M415004 定制化选择 也可以根据您的需求 定制颜色, 请联系我们。
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途: (a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。