EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

No. CE 616020Issued To: Medical Components, Inc.

dba Medcomp1499 Delp DriveHarleysvillePennsylvania19438USA

In respect of:

Design, development and manufacture of non-sterile ECG-based peripherally inserted centralcatheter placement and tip location confirmation systems.

Those aspects of Annex II concerned with securing and maintaining sterile conditions ofaccessories for ECG-based peripherally inserted central catheter placement and tip locationconfirmation systems.

on the basis of our examination of the quality assurance system under the requirements of Council Directive93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. Forthe 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 0086):

Frank Lee, EMEA Compliance & Risk Director

First Issued: 15 May 2015 Date: 11 September 2015 Expiry Date: 14 May 2020

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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 requiredsurveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the companynamed 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, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Lextech Global Services1431 Opus PlaceSuite 200Downers GroveIllinois60515USA

Software

Martech East1500 Delp DriveHarleysvillePennsylvania19438USA

Manufacture

MPS Medical Product Service GmbHBorngasse 2035619 BraunfelsGermany

EU Representative

EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

Certificate No: CE 616020Date: 11 September 2015Issued To: Medical Components, Inc.

dba Medcomp1499 Delp DriveHarleysvillePennsylvania19438USA

Subcontractor: Service(s) supplied

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Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Nostix, LLC5541 Central Avenue, Suite 170BoulderColorado80301USA

DesignManufacture

Sterigenics5725 West Harold Gatty DriveSalt Lake CityUtah 84116USA

ETO Sterilization

The Electronic Assembly Company150 South Front St.SoudertonPennsylvania18964USA

Manufacture

EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

Certificate No: CE 616020Date: 11 September 2015Issued To: Medical Components, Inc.

dba Medcomp1499 Delp DriveHarleysvillePennsylvania19438USA

Subcontractor: Service(s) supplied

Page 2 of 3

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

VPI Technology Group11814 S. Election RoadSuite 200DraperUtah84020USA

Software

EC Certificate - Full Quality Assurance SystemDirective 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

Certificate No: CE 616020Date: 11 September 2015Issued To: Medical Components, Inc.

dba Medcomp1499 Delp DriveHarleysvillePennsylvania19438USA

Subcontractor: Service(s) supplied

Page 3 of 3

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

EC Certificate - Full Quality Assurance System

Certificate History

Certificate No: CE 616020Date: 11 September 2015Issued To: Medical Components, Inc.

dba Medcomp1499 Delp DriveHarleysvillePennsylvania19438USA

Page 1 of 1

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the companynamed 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, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Date ReferenceNumber Action

15 May 2015 8177168 First Issue11 September 2015 8360908 Addition of significant subcontractors; The Electronic Assembly

Company for Manufacture, Martech East for Manufacture, VPITechnology Group for software, and Lextech Global Services forsoftware.