MAKERS OF RESPIRATORY VALVES SINCE 1938

HANS RUDOLPH, inc. 8325 Cole Parkway • Shawnee, KS 66227 USA

PH: (913) 422-7788 USA & Canada: (800) 456-6695 ISO 13485 :2016

Quali

Quality Management System (QMS) is certified to the following Standards:

FAX: (913) 422-3337 hri@rudolphkc.com www.rudolphkc.com

tern

ISO 13485 through BSI. HRI has a CE Certificate through BSI for Full Quality Assurance Approval per Annex II of the EC Council Directive 93/42/EEC, certificate CE 598572. HRl's QMS also meets the U.S.A. FDA (Food & Drug Administration) Good Manufacturing Practices- Quality System Regulation (GMP-QSR), including the FDA-MDR (Medical Device Reporting), the European Commission "Medical Devices Vigilance System", and the Canadian MDR Medical Devices Regulations SORl98-282.

E C Rep Ltd. 5 Fitzwilliam Square East Dublin 2, D02 R744, Ireland

Phone: +353 1 2 544 944 Email : info@ecrep.ie

Hans Rudolph, inc. QMS uses controlled documents, which are employed as the Quality Assurance Manual, Operating Procedures, Work Instructions and Tests Methods.

Best Regards,

Lee A. Stroh Quality Assurance Manager Management Representative

791281-11

August 6, 2019

DeN: 31756

bsi. Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016

This is to certify that:

Holds Certificate No:

Hans Rudolph, inc. 8325 Cole Parkway Shawnee Kansas 66227 USA

FM 598075

By Royal Charter

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the following scope:

The designer, manufacturer, and distributor of respiratory valves, face masks, pneumotachometer, volumetric calibration syringes, and respiratory accessories, for hospitals, universities, and original equipment manufacturers.

•

For and on behalf of BSI: Stewart Brain, Head of Compliance & Risk - Medical Devices

Original Registration Date: 2013-05-28

Latest Revision Date: 2019-06-13

Effective Date: 2019-08-05

Expiry Date: 2022-08-04

IICCA ...... _ Page: 1 of 1 o eelM

Acc~"' CCN ... making excellence a habit:"

This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.comj ClientDirectory To be read in conjunction with the scope above or the attached appendix.

Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.

bsi. By Royal Charter

EC Certificate - Full Quality Assurance System Directive 93j42jEEC on Medical Devices, Annex II excluding Section 4

No.

Issued To:

In respect of:

CE 598572

Hans Rudolph, inc. 8325 Cole Parkway Shawnee Kansas 66227 USA

The design, development and manufacture of non-sterile respiratory valves, masks, connectors, gas bags and pneumotachometers.

on the basis of our examination of the quality assurance system under the requirements of Council Directive 93j42jEEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required .

For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):

Gary E Slack, Senior Vice President Medical Devices

First Issued: 2013-07-05 Date: 2019-09-06 Expiry Date: 2024-05-26

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Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonst rated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/ or manufactured by a third party on behalf of the company named on this certificate, unless speCifically agreed with BSI. This certif icate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI , Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 3460780 BSI Group The Net herlands B.V. reg istered in The Netherlands under 33264284. A member of BSI Group of Companies.

bsi. By Royal Charter

EC Certificate - Full Quality Assurance System

Supplementary Information to CE 598572

Issued To:

Number

Class IIa

MD 0101

MD 0101

MD 0101

MD 0101

MD 0101

MD 0101

MD 0106

MD 0106

MD 0106

MD 0101

Device name

Hans Rudolph, inc. 8325 Cole Parkway Shawnee Kansas 66227 USA

One Way Respiratory Valves

Two Way Non-Rebreathing Valve

Inflatable Balloon-Type Valves

Mouthpieces

Face Mask with Two-Way Valves

Respiratory Connectors Accessory

Manual and Pneumatic Valves

Linear Pneumotachometer

Non-Diffusing Gas Bag

Oro-Nasal Masks

First Issued: 2013-07-05 Date: 2019-09-06

Intended purpose

N/A

Expiry Date: 2024-05-26

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Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/ or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 203460780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.

bsi. By Royal Charter

EC Certificate - Full Quality Assurance System Directive 93j42jEEC on Medical Devices, Annex II excluding Section 4

List of Significant Subcontractors Recognised as being involved in services relating to the product covered by:

Certificate No:

Date:

Issued To:

Subcontractor:

E C Rep Ltd.

CE 598572

2019-09-06

Hans Rudolph, inc. 8325 Cole Parkway Shawnee Kansas 66227 USA

S Fitzwilliam Square East Dublin 2 002 R744 Ireland

Service(s) supplied

EU Representative

... making excellence a habif"

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.

Page 1 of 1

bsi. By Royal Charter

EC Certificate - Full Quality Assurance System Certificate History

Certificate No:

Date:

Issued To:

Date

05 July 2013

09 September 2014

24 January 2019

Current

CE 598572

2019-09-06

Hans Rudolph, inc. 8325 Cole Parkway Shawnee Kansas 66227 USA

Reference Number

7984855

8215131

8901991

9788297

Action

First issue. Transfer from another Notified Body.

Certificate renewal.

Traceable to NB 0086.

Certificate renewal.

Change of certificate scope to include "non-sterile".

Change of details for EU Representative .

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Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a t hird party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI , Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.