POLYONE FRANCE TOSSIAT 43, PLACE DE LA GARE 01250 TOSSIAT FRANCE Bureau Veritas Certification France certify that the Management System of the above organization has been audited and found to be in accordance with the requirements of the management system standard detailed below: Standard ISO 14001:2015 Scope of certification THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR THERMOPLASTICS Certification/Recertification Cycle Start Date: 03 May 2023 Subject to the continued satisfactory operation of the organization’s Management System, this certificate expires on: 02 May 2026 Expiry date of previous cycle: NA Certification/Recertification Audit date: 08 March 2023 Original Cycle Start Date: 15 July 2011 Certificate n°: FR081968-1 File n°:15608678 Revision date:24 April 2023 Laurent CROGUENNEC - President Local Office: Bureau Veritas Certification France Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense Further clarifications regarding the scope of this certificate the applicability of the management system requirements may be obtained by consulting the organization.

F-27, MIDC, Ranjangaon, Shirur, Pune, Maharashtra 412 220 India ISO 45001:2018 The Occupational Health and Safety Management is applicable to: Certificate No: 55689 Certification Date: 15 March 2017 Effective Date: 09 March 2023 Expiration Date: 14 March 2026 Revision Date: 15 March 2023 Dominic Townsend, President DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY COMPOUNDS.

Limited PO Box 2137, Jeddah 22758 Saudi Arabia Has been assessed and found to meet the requirements of ISO 14001:2015 This certificate is valid for the following scope of operations: Production and Supply of Color and Additive Master Batches Authorised by: Stan Wright Director Date of Certificate Issue: 20 December 2022 Certificate Valid Until: 19 December 2025 Recertification audit before 20 November 2025.

Park, China (Shanghai) Pilot Free Trade Zone, Shanghai, China 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Colour and Additive Concentrates http://www.dnv.com/assurance

240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com

Versaflex™ & Versalloy™ Specialty Engineered Materials Thermoplastic Elastomers for Healthcare Applications Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications, Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5. VERSAFLEX™ HC MEDICAL TUBING GRADES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Traditional and bio- based formulations specifically for biopharmaceutical tubing to meet the needs for weldability and minimize extractables during processing VERSALLOY™ HC SERIES • Obtain better flow in long, thin paths and lower shrink rates versus typical TPVs with our alloys • Color easily and obtain a smooth tactile feel VERSAFLEX™ HC GASKETS & STOPPERS SERIES • Achieve no coring, good puncture and resealability in static stoppers • Meet low COF and low stiction requirements in dynamic seals CL E SERIES • Increase clarity and flexibility in bags, bottles and films • Mitigate risk with plasticizer-free formulations for film extrusion • Deliver excellent odor & O2 barrier performance for film extrusion INDUSTRY BULLETIN TPE HEALTHCARE PRODUCT SELECTOR GUIDE Versaflex™ HC Medical Tubing Grades Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔ High clarity, without plasticizersVersaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔ Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔ Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant Versalfex™ HC BIO BT218 Natural 70A 0.88 18 58 416 2.87 668 4.60 1190 8.20 630 - - ✔ ✔ Weldable, kink resistant, contains 40% bio-derived content (Gen 1 biomass) Versaflex™ HC Gaskets & Stoppers Series Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction Versaflex™ CL E Series Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔ High clarity, without plasticizers; E95 also offers excellent odor & O2 barrier Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔ Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔ Versaflex™ HC 3810 Series Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ - Formulated without animal derivatives, excellent colorability, translucent Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ - Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ - Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ - Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ - Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ - Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ - Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ - Versalloy™ HC 9210 Series Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔ Smooth surface aestheticsVersalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔ Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔ Versalloy™ HC 9220 Series Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔ ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔ Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔ Standard Healthcare Grades Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔ High clarity, boilable Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔ Versaflex™ OM Series Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔ Versaflex™ OM 8940X-1 Clear 42A 0.91 - - 233 - 311 - 1573 - 1059 - - - - PK, COPE overmold Versaflex™ OM 4052 Natural 56A 1.01 27 - 271 - 557 - 1680 - 670 - - ✔ - Excellent chemical resistance; PK, PC, ABS, PC/ABS overmoldVersaflex™ OM 4063 Natural 54A 1.12 30 - 365 - 580 - 1640 - 670 - - ✔ - Color Hardness Specific Gravity Compression Set @ 23°C Compression Set @ 100°C 100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength ISO 10993 USP VI Special Characteristics ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi MPa ASTM psi MPa ASTM psi ISO MPa ASTM % ASTM pll ISO kN/m GENERAL PROPERTIES TENSILE PROPERTIES OTHER For further information on specific grades, review technical data sheets.

MEVOPUR Colors for Needle Hubs Bulletin_CN * 可根据要求提供FDA/EU合规信息 应用公告 MEVOPUR™用于针头和导管座的 标准颜色 为了帮助我们的客户满足医疗行业标准要求，埃 万特开发了一系列符合ISO 6009标准颜色编码的 针座、导管座和翼梁的标准颜色。 主要特性 在三个通过ISO 13485认证的医疗生产线生 产全球统一的配方，提供全球一致性和供应 链保障 变更控制记录不限于CAS编号级别，降低变 更风险 不含动物源性物质和邻苯二甲酸盐 可将颜色与添加剂相结合，以增强产品性能 和防护性能 法规支持 经过预测试的原材料： - 美国药典（USP）23，第87和88章（VI类） 萃取和生物学评价 - ISO 10993，第4、5、10、11和18部分， 萃取和生物学评价 - 美国药典和欧洲药典中针对USP 、 ICH Q3D可萃取金属和EP3.1聚烯烃的测试的 其他监管支持信息 FDA器械主文件 食品接触符合FDA/EU*要求 针头的标称外径 （mm） 颜色说明 RAL 潘通色号 透明产品代码 不透明产品代码 0.4 中灰色 7035 423 C PP7M665125 PP7M665127 0.45 褐色 8017 7588 C PP8M665294 PP8M665296 0.5 橘黄色 2003 173 C PP2M665298 PP2M665300 0.55 中紫色 4005 7676 C PP4M665290 PP4M665292 0.6 深蓝色 5010 288 C PP5M665894 PP5M665896 0.7 黑色 9005 黑色 C PP9M664950 PP9M664952 0.8 深绿色 6001 7483 C PP6M665687 PP6M665689 0.9 黄色 1021 115 C PP1M665211 PP1M665213 1.1 乳白色 1015 7401 C PP0M665290 PP0M665292 1.2 粉色 3015 502 C PE3M665725 PP3M665727 适用医疗保健使用限制—见下文。 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。

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。

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 • 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 • 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, HC 9210-55N 55A USP Class VI EtO Good processability, HC 9210-70N 70A USP Class VI EtO Good processability, 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.

ABS Quality Evaluations This is to certify that the Quality Management System of: Avient Corporation Avient Corporation - McHenry, IL 831 Ridgeview Drive ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 45324 Certification Date: 24 February 2014 Effective Date: 13 January 2023 Expiration Date: 23 January 2026 Revision Date: 13 January 2023 Dominic Townsend, President DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE MEDICAL DEVICE INDUSTRY This certificate may be found on the ABS QE Website (www.abs-qe.com). 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 ISO 13485:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.