CERTIFICATE OF REGISTRATION

TEKNA Manufacturing Pvt. Ltd.

C-19, Industrial Estate, Guindy Chennai, Tamil Nadu 600032 INDIA

UL Medical Regulatory Services of UL LLC®(UL) issues this certificate to the Firm named above, after auditing the Firm’s quality management system and finding it in conformance per the defined scope with respect to:

ISO 13485:2016

with additional regulatory requirements listed on final page of this certificate. The design, manufacture, service and installation of hyperbaric chambers.

Authorized by

Michael J. Windler, P.E. Manager of Global Regulatory Service Distinguished Member of the Technical Staff UL Life and Health Sciences
UL LLC

Check Certificate

Status: here

REPs Facility ID:

File Number Certificate Number Initial Issue Date

A28843 3017.200413 April 13, 2020

Cycle Start Date Effective Date Expiry Date

April 13, 2020 April 13, 2020 April 12, 2023

This quality system registration is included in UL’s Directory of Registered Firms and applies to the provision of goods and/or services as specified in the scope of registration from the address(es) shown above. By issuance of this certificate the firm represents that it will maintain its registration in accordance with the applicable requirements. This certificate is not transferable and remains the property of UL Medical and Regulatory Services of UL LLC.

Certificates may be verified by visiting the Online Certifications Directory on UL.com.

00-MB-F0867 Issue 1.0 Page 1 of 2

UL Medical and Regulatory Services UL, LLC is an MDSAP Recognized Auditing Organization

UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 USA

UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2011.

CERTIFICATE OF REGISTRATION

TEKNA Manufacturing Pvt. Ltd.

C-19, Industrial Estate, Guindy Chennai, Tamil Nadu 600032 INDIA

Additional Regulatory Requirements

REPs Facility ID:

Australia:
– Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure

Brazil:
– RDC ANVISA n. 16/2013 – RDC ANVISA n. 23/2012 – RDC ANVISA n. 67/2009

Canada:
– Medical Devices Regulations – Part 1- SOR 98/282

Japan:
– MHLW Ministerial Ordinance 169, Article 4 to Article 68 – PMD Act (,as applicable)

United States:

• –  21 CFR 820

• –  21 CFR 803

• –  21 CFR 806

  – 21 CFR 807 – Subparts A to D

– 21 CFR 821 (where applicable)

File Number Certificate Number Initial Issue Date

A28843 3017.200413 April 13, 2020

Cycle Start Date Effective Date Expiry Date

April 13, 2020 April 13, 2020 April 12, 2023

This quality system registration is included in UL’s Directory of Registered Firms and applies to the provision of goods and/or services as specified in the scope of registration from the address(es) shown above. By issuance of this certificate the firm represents that it will maintain its registration in accordance with the applicable requirements. This certificate is not transferable and remains the property of UL Medical and Regulatory Services of UL LLC.

Certificates may be verified by visiting the Online Certifications Directory on UL.com.

00-MB-F0867 Issue 1.0 Page 2 of 2

UL Medical and Regulatory Services UL, LLC is an MDSAP Recognized Auditing Organization

UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 USA

UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2011.