The ANSI National Accreditation Board

1 CERTIFICATE OF Accreditation . The ANSI National Accreditation Board Hereby attests that North American Science Associates, LLC. (NAMSA). 6750 Wales Road Northwood, OH 43619. Fulfills the requirements of ISO/IEC 17025:2017. and FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Biocompatibility Testing of Medical Devices and Good Laboratory Practice for Nonclinical Laboratory Studies, Title 21. CFR Part 58 Accreditation Program In the field of TESTING. This certificate is valid only when accompanied by a current scope of Accreditation document. The current scope of Accreditation can be verified at _____. R. Douglas Leonard Jr., VP, PILR SBU. Expiry Date: 09 March 2024. Certificate Number: AT-2561.

2 This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017. This Accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqu dated April 2017). SCOPE OF Accreditation TO ISO/IEC 17025:2017. FDA Accreditation SCHEME FOR CONFORMITY ASSESSMENT (ASCA). PILOT PROGRAM - BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES 1. GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES, TITLE 21 CFR PART 58 Accreditation PROGRAM 2. North American Science Associates, LLC (NAMSA). 6750 Wales Road Northwood, OH 43619. Valerie D. Gnepper 419-666-9455. TESTING. Valid to: March 09, 2024 Certificate Number: AT-2561.

3 Testing to meet the requirements of ANAB Supplemental Requirements SR 2438, FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Biocompatibility Testing of Medical Devices 1. Specification, Items, Materials, Specific Tests and/or Standard, Method, or Key Equipment or Technology Properties Measured or Test Technique Product Tested ISO 10993-4 Third edition 2017-04. Biological evaluation of medical devices- SC5b-9 Complement Part 4; Spectrophotometer Medical Devices Activation (TM_00179) ISO 10993-12 Fourth (minimum range: 200 1000 nm). -edition 2012-07-01- Biological evaluation of medical devices . Part 12. Version 014 Issued:February 28, 2022 Page 1 of 8. Testing to meet the requirements of ANAB Supplemental Requirements SR 2438, FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Biocompatibility Testing of Medical Devices 1.

4 Specification, Items, Materials, Specific Tests and/or Standard, Method, or Key Equipment or Technology Properties Measured or Test Technique Product Tested ISO 10993-4 Third edition 2017-04. Biological evaluation of medical devices- Incubator (37 C 1 C) or (50 /70 C 2 C). Part 4; Autoclave (121 C 2 C). Direct and Indirect ASTM F756-17; Medical Devices Spectrophotometer Hemolysis (TM_00177). ISO 10993-12 Fourth (minimum range: 200-1000 nm). edition 2012-07-01 Centrifuge (minimum range: 600-4000 rpm). Biological evaluation of medical devices . Part 12;. ISO 10993-5 Third edition 2009-06-01. Biological evaluation of medical devices . MEM Elution Part 5; Medical Devices Shaker-incubator (37 C 1 C). Cytotoxicity (TM_00168) ISO 10993-12 Fourth Incubator (37 C 1 C) and (5% CO2 1% CO2 ).

5 Edition 2012-07-01. Biological evaluation of medical devices . Part 12. ISO 10993-10 Third edition 2010-08-01. Biological evaluation of medical devices . Skin Irritation Part 10; Shaker-incubator (37 C 1 C) or (50 /70 C 2 C). Medical Devices (TM_00136) ISO 10993-12 Fourth Autoclave (121 C 2 C). edition 2012-07-01. Biological evaluation of medical devices . Part 12. Version 014 Issued:February 28, 2022 Page 2 of 8. Testing to meet the requirements of ANAB Supplemental Requirements SR 2438, FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Biocompatibility Testing of Medical Devices 1. Specification, Items, Materials, Specific Tests and/or Standard, Method, or Key Equipment or Technology Properties Measured or Test Technique Product Tested ISO 10993-10 Third edition 2010-08-01.

6 Biological evaluation of medical devices . Intracutaneous Reactivity Part 10; Shaker-incubator (37 C 1 C) or (50 /70 C 2 C). Medical Devices Irritation (TM_00129) ISO 10993-12 Fourth Autoclave (121 C 2 C). edition 2012-07-01. Biological evaluation of medical devices . Part 12. ISO 10993-10 Third edition 2010-08-01. Closed Patch Sensitization Biological evaluation Medical Devices Not applicable (TM_00134). of medical devices . Part 10;. ISO 10993-10 Third edition 2010-08-01. Biological evaluation of medical devices . Part 10;. Guinea Pig Maximization ASTM F720-17; Medical Devices Shaker-incubator (37 C 1 C) or (50 /70 C 2 C). Sensitization (TM_00135) Autoclave (121 C 2 C). ISO 10993-12 Fourth edition 2012-07-01.

7 Biological evaluation of medical devices . Part 12. ISO 10993-11 Third edition 2017-09. Biological evaluation of medical devices . Shaker-incubator (37 C 1 C) or (50 /70 C 2 C). Acute Systemic Toxicity Part 11;. Medical Devices Autoclave (121 C 2 C). (TM_00157) ISO 10993-12 Fourth Balance (calibrated daily prior to use). edition 2012-07-01. Biological evaluation of medical devices . Part 12. Version 014 Issued:February 28, 2022 Page 3 of 8. Testing to meet the requirements of ANAB Supplemental Requirements SR 2438, FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Biocompatibility Testing of Medical Devices 1. Specification, Items, Materials, Specific Tests and/or Standard, Method, or Key Equipment or Technology Properties Measured or Test Technique Product Tested ISO 10993-11 Third edition 2017-09.

8 Biological evaluation of medical devices . Part 11; Shaker-incubator (37 C 1 C) or (50 /70 C 2 C). Material-Mediated USP<151>; Medical Devices Autoclave (121 C 2 C). Pyrogenicity (TM_00116). ISO 10993-12 Fourth Probes ( C). edition 2012-07-01. Biological evaluation of medical devices . Part 12. Chemical Specific Tests and/or Specification, Standard, Items, Materials or Key Equipment or Properties Measured Method, or Test Technique Product Tested Technology ultra performance liquid ultra performance liquid Polymers, Metals, Assembled chromatography -Mass ISO 10993-18 Chromatograph (UPLC . Devices, Materials Spectrometry (UPLC-MS) qTOF). Gas chromatography -Mass Polymers, Metals, Assembled Gas Chromatograph - Mass ISO 10993-18.

9 Spectrometry (GC-MS) Devices, Materials Spectrometer (GC-MS). Inductively Coupled Plasma- Polymers, Metals, Assembled Inductively Coupled Plasma - ISO 10993-18. Mass Spectrometry (ICP-MS) Devices, Materials Mass Spectrometer (ICP-MS). Inductively Coupled Plasma- Inductively Coupled Plasma- Polymers, Metals, Assembled Optical Emission ISO 10993-18 Optical Emission Devices, Materials Spectroscopy (ICP-OES) Spectrometer (ICP-OES). Polymers, Metals, Assembled Ion chromatography (IC) ISO 10993-18 Ion Chromatograph (IC). Devices, Materials USP <197>; Polymers, Non-Volatile Infrared Analysis (IR) FTIR Spectrophotometer USP <854> Residue, Particulates Exhaustive and Exaggerated Polymers, Metals, Assembled Balances, Rotary Evaporator, ISO 10993-18.

10 Extraction Devices, Materials Incubators Preliminary and Exaggerated Balances, Rotary Evaporator, MHLW Finished Medical Devices Extraction Incubators Version 014 Issued:February 28, 2022 Page 4 of 8. Chemical Specific Tests and/or Specification, Standard, Items, Materials or Key Equipment or Properties Measured Method, or Test Technique Product Tested Technology FTIR Spectrophotometer, Balances, Rotary Evaporator, Characterization of Plastic USP38-NF33 <661>; Incubators, pH Meter, UV- Materials of Construction and USP <381>; Polymers, Containers, Vis Spectrophotometer, ICP- Elastomeric Closures USP < >; Closures MS, Differential Scanning (including Physicochemical USP < > Calorimeter, Testing). chromatography , GC-MS, ICP-MS, UPLC-MS.