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CMDCAS-13485-MSP-US (2.0)

Page 1 of 2

Certificate of Registration

of Quality Management System to ISO 13485:2003

The National Standards Authority of Ireland

A CMDCAS Recognized Registrar certifies that:

Lumitex Medical Devices, Inc.

8443 Dow Circle

Strongsville, OH 44136

USA has been assessed and deemed to comply with the requirements of the above standard in respect of the scope of operations given below:

Design and Development, Production, Contract

Manufacturing and Distribution of Sterile and

Non-sterile Medical Illumination Devices and

Non-sterile Phototherapy Devices.

Additional sites covered under this multi-site certification are listed on the

Attachment (File No. CM19.4787)

Approved by:

Geraldine Larkin

Chief Executive Officer

Approved by:

Eoin Banville

Operations Manager,

Medical Devices

Certificate Number: CM19.4787

Certification Granted: Mar 26, 2013

Effective Date: Aug 11, 2017

Expiry Date: Dec 31, 2018

National Standards Authority of Ireland, 1 Swift Square, Northwood, Santry, Dublin 9, Ireland T +353 1 807 3800

National Standards Authority of Ireland, 20 Trafalgar Squaret, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412

CMDCAS-13485-MSP-US (1.1)

Page 2 of 2

Attachment 1 to Certificate Number: CM19.4787

Scope of Registration :

Design and Development, Production, Contract Manufacturing and Distribution of Sterile and Non-sterile Medical Illumination

Devices and Non-sterile Phototherapy Devices.

Activity Location

Headquarters, Administration,

Quality Assurance, Regulatory

Affairs, Production, Design and

Development

Lumitex Medical Devices, Inc.

8443 Dow Circle

Strongsville, OH 44136

USA

File No.: CM19.4787

Quality Assurance, Regulatory

Affairs, Production, and Design

and Development Lumitex Medical Devices, Inc.

8300 Dow Circle

Suite 400

Strongsville, OH 44136

USA

File No.: CM19.4787/A

Verified by:

Operations Manager

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