LIVEON BIOLABS PRIVATE

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(A2LA Cert. No. 7701.01) 8/3/2026 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 LIVEON BIOLABS PRIVATE LIMITED Plot No. 46 & 47, II Phase, Water Tank Road, KIADB, Industrial Area Antharasanahalli, Tumakur, Karnataka, INDIA Mr. Shivashankar N.G. Phone: +919480849739 BIOLOGICAL Valid To: June 30, 2028 Certificate Number: 7701.01 In recognition of the successful completion of the A2LA evaluation process, (including an assessment of the organization’s compliance with U.S. FDA Good Laboratory Practice (GLP) Regulations per 21 CFR Part 58 1), accreditation is granted to this laboratory to perform the following tests on medical devices: Test Test Methods Abnormal Toxicity Test Indian Pharmacopeia and Russian Pharmacopeia Volume II, Ninth Edition, pg.1866 Acute Systemic Toxicity ISO 10993 (Part 11), USP 88 Bacterial Reverse Mutation Test ISO 10993 (Part 3), (Part 33) In Vitro – CHO Cell lines/In Vivo Mammalian Erythrocyte Micronucleus Test ISO 10993 (Part 3), (Part 33) In-Vitro Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene and Mouse Lymphoma Assay Using L5178YK ISO 10993 (Part 3) (Part 33) In-Vitro-CHO Cell lines/In Vitro Chromosomal Aberration Test ISO 10993 (Part 3) (Part 33) In Vitro Cytotoxicity Test ISO 10993 (Part 5) In Vivo Pyrogenicity ISO 10993 (Part 11)) (USP Chapter <151>) Intracutaneous (Intradermal) Reactivity Test in Rabbits ISO 10993 (Part 23), USP 88 Skin, Ocular, Vaginal, Penile, Rectal Irritation Tests in Rabbits and Oral Mucosal Irritation in Hamster ISO 10993 (Part 23) Skin Sensitization in Guinea Pigs ISO 10993 (Part 10) Tests for Interactions with Blood for Hemolysis Direct Method / Hemolysis Indirect Method ISO 10993 (Part 4) Tests for Local Effects After Implantation in Rat & Rabbit (Bone, Muscle, Subcutaneous) ISO 10993 (Part 6) In-Vitro Skin Irritation ISO 10993 -23/Amd 1 1Assessment to the U.S. FDA GLP (21CFR58) Regulations does not imply acceptance by the FDA

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For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation. Accredited Laboratory A2LA has accredited LIVEON BIOLABS PRIVATE LIMITED Tumakur, INDIA for technical competence in the field of Biological Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 3rd day of August 2026. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 7701.01 Valid to June 30, 2028