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1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - English Document Number: W-QMS-FRM-40026 Revision: 3 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for most recent version unless formally issued and stamped by QA. Created with W-QMS-TEM-00001 R.2 EC DECLARATION OF CONFORMITY (EN) We LumiraDx Inc 221 Crescent street Waltham, MA 02453 United States of America hereby declare under our sole responsibility that the product, Product Name: LumiraDx Connect Hub Identifier: 720-10002-01 to which this declaration relates, is in conformity with the harmonized standards and specifications listed in the appendix, and the following European directives as transposed into the national laws of the member states: Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making available on the market of radio equipment and replacing Directive 1999/5/EC Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical or electronic equipment Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility (recast) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits and as such the product bears the CE mark. Signed for and on behalf of LumiraDx Inc: Signature Name Dorian LeBlanc Title CFO Date (YYYY-MM-DD) 2019-05-24 APPENDIX A List of Harmonized Standards used EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

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Page 1: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - English

Document Number: W-QMS-FRM-40026 Revision: 3

This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for most recent version unless formally issued and stamped by QA. Created with W-QMS-TEM-00001 R.2

EC DECLARATION OF CONFORMITY (EN)

We LumiraDx Inc 221 Crescent street Waltham, MA 02453 United States of America

hereby declare under our sole responsibility that the product,

Product Name: LumiraDx Connect Hub

Identifier: 720-10002-01

to which this declaration relates, is in conformity with the harmonized standards and specifications listed in the appendix, and the following European directives as transposed into the national laws of the member states:

• Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making available on the market of radio equipment and replacing Directive 1999/5/EC

• Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical or electronic equipment

• Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility (recast)

• Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits

and as such the product bears the CE mark.

Signed for and on behalf of LumiraDx Inc:

Signature

Name Dorian LeBlanc

Title CFO

Date (YYYY-MM-DD) 2019-05-24

APPENDIX A

List of Harmonized Standards used EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

Page 2: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish

Document Number: W-QMS-FRM-40035 Revision: 1 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

most recent version unless formally issued and stamped by QA. Created with W-QMS-TEM-00001 R.2

EF-OVERENSSTEMMELSESERKLÆRING (DA)

Vi LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America

hermed erklærer vi på eget ansvar at produktet

Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

som erklæringen vedrører, er i overensstemmelse med de harmoniserede standarder og specifikationer, der er anført i tillægget, og følgende europæiske direktiver, der er gennemført i medlemsstaternes nationale lovgivning:

• Europa-Parlamentets og Rådets Direktiv 2014/53/EU af 16. April 2014 om harmonisering af medlemsstaternes love om tilgængeliggørelse af radioudstyr på markedet og om ophævelse af direktiv 1999/5/EF

• Europa-Parlamentets og Rådets Direktiv 2011/65/EU af 8. Juni 2011 om begrænsing af anvendelsen af visse farlige stoffer i elektrisk og elektronisk udstyr

• Europa-Parlamentets og Rådets Direktiv 2014/30/EU af 26. Februar 2014 om harmonisering af medlemsstaternes lovgivning om elektromagnetisk kompatibilitet

• Europa-Parlamentets og Rådets Direktiv 2014/35/EU af 26. Februar 2014 om harmonisering af medlemsstaternes love om tilgængliggørelse på markedet af elektrisk materiel bestemt til anvendelse inden for visse spændingsgrænser

og som sådan bærer produktet CE-mærket

Underskrevet for og på vegne af LumiraDx Inc.

Underskrevet

Navn Dorian LeBlanc

Titel CFO

Dato (YYYY-MM-DD) 2019-05-24

Bilag A Liste over Harmoniserede Standarder brugte

EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

Page 3: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document
Page 4: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - German

Document Number: W-QMS-FRM-40028 Revision: 3 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

most recent version unless formally issued and stamped by QA. Created with W-QMS-FRM-40028 R.2

EG-KONFORMITÄTSERKÄRUNG (DE)

Wir: LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America erklären, in alleniniger Verantwortung,daß das Produkt, Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

die Erklärung, auf die sich diese Erklärung bezieht, den im Anhang aufgeführten harmonisieren Normen und Spezifikationen sowie den folgenden europäischen Richtlinien, die in das nationale Recht der Mitgliedstaaten umgesetzt wurden:

• Richtlinie 2014/53/EU des Europäischen Parlaments und des rates com 16. April 2014 über die Harmonisierung der Rechtsvorschriften der Mitgliedstaaten über die Bereitstellung von Funkanlagen auf dem Markt und zur Aufhebung der Richtlinie 1999/5/EG

• Richlinie 2011/64/EU des Europäischen Parlaments und des Rates vom 8. Juni 2011 zur Beschränkung der Verwendung bestimmter gefährlicher Stoffe in Elektro-und Electronikgeräten

• Richtlinie 2014/30/EU des Europäischen Parlaments und des Rates vom 26. Februar 2014 zur Harmonisierung der Rechtsvorschriften der Mitfliedstaaten über die elektromagnetische Verträglichkeit

• Richtlinie 2014/35/EU des Europäischen Parlaments und des Rates vom 26. Februar 2014 zur Harmonisierung der Rechtsvorschriften der Mitgliedstaaten über die Bereitstellung elektrischer Betriebsmittel zur Verwendung innerhalb bestimmter Spannungsgrenzen auf dem Markt

als solches trägt das Produkt das CE-Zeichen Unterzeichnet für und in Namen von LumiraDx Inc: Signiert

Name Dorian LeBlanc

Title CFO

Date (YYYY-MM-DD) 2019-05-24

Anhang A

Liste der Harmonisierter Standard verwendeten EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

Page 5: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Spanish

Document Number: W-QMS-FRM-40027 Revision: 3 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

most recent version unless formally issued and stamped by QA. Created with W-QMS-TEM-00001 R.2

DECLARACIÓN CE DE CONFORMIDAD

(ES) Nosotros: LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America declaramos, bajo nuestra sola responsabilidad, que el producto, Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

a la que se refiere esta declaración, está en conformidad con las normas y especificaciones armonizadas que se enumeran en el apéndice, y las siguientes directivas europeas que se incorporan a las leyes nacionales de los estados miembros:

• Directiva 2014/53/UE del Parlamento Europeo y del Consejo de 16 de abril de 2014 relativa a la armonización de las legislaciones de los Estados miembros sobre la comercialización de equipos radioeléctricos, y por la que se deroga la Directiva 1999/5/CE

• Directiva 2011/65/UE del Parlamento Europeo y Del Consejo de 8 de junio de 2011 sobre restricciones a la utilización de determinadas sustancias peligrosas en aparatos eléctricos y electrónicos

• Directiva 2014/30/UE del Parlamento Europeo y del Consejo de 26 de febrero de 2014 sobre la armonización de las legislaxiones de los Estados miembros en materia de compatibilidad electromagnética

• Directiva 2014/35/UE del Parlamento Europeo y del Consejo de 26 de febrero de 2014 sobre la armonización de las legislaciones de los Estados miembros en materia de comercialización de material eléctrico destinado a utilizarse con determinados límites de tensión

y como tal el product lleva la marca CE. Firmado para y en representacion de LumirDx Inc: Firmado

Name Dorian LeBlanc

Title CFO

Date (YYYY-MM-DD) 2019-05-24

Apéndice A

Lista de Norma Armonizada usados EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

Page 6: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - French

Document Number: W-QMS-FRM-40030 Revision: 3 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

most recent version unless formally issued and stamped by QA. Created with W-QMS-FRM-40030 R.2

DÉCLARATION CE DE CONFORMITÉ (FR)

Nous: LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America déclarons sous notre seule responsabilité que le produit, Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

auquel se rapporte cette declaration est conforme aux norms et specifications harmonises énumérées dans l’annexe, ainsi qu’aux directives européennes suivantes tranposées dans le droit national des États membres:

• Directive 2014/53/UE du Parlement Européen et du Conseil du 16 avril 2014 relative à l’harmonisation des législations des États membres concernant la mise à disposition sur le marché d’équipements radioélectriques et abrogeant la directive 1999/5/CE

• Directive 2011/65/UE du Parlaments Européen et du Conseil du 8 juin 2011 relative à la limitation de l’utilisation de certaines substances dangereuses dans les équipements électriques et électroniques

• Directive 2014/30/UE du Parlement Européen et du Conseil du 26 février 2014 relative à l’harmonisation des législations des États membres concernant la compatibilité électromagnétique

• Directive 2014/35/UE du Parlement Européen et du Conseil du 26 février 2014 relative à l’harmonisation des législations des États membres concernant la mise à disposition sur le marché dy matériel électrique destiné à être employé dans certaines limites de tension

et en tant que tel, le produit porte la marque CE. Signé pour et au nom de LumiraDx Inc: Signé

Name Dorian LeBlanc

Title CFO

Date (YYYY-MM-DD) 2019-05-24

Annexe A

Liste des Norme Harmonisée utilisés EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

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1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Italian

Document Number: W-QMS-FRM-40031 Revision: 3

This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for most recent version unless formally issued and stamped by QA. Created with W-QMS-FRM-40031 R.2

DICHIARAZIONE CE DI CONFORMITÀ (IT)

Noi: LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America dichiariamo sotto la propria responsabilit à, che il prodotto, Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

alla quale si riferisce la presente cichiarazione, è conforme alle norme e alle specifiche armonizzate elencate nell’appendice e alle seguenti direttive europee recepite nelle leggi nazionali degli Stati membri:

• Direttiva 2014/53/UE del Parlamento Europeo e del Consiglio del 16 aprile 2014 concernente l’armonizzazione delle legislazioni degli Stati membri relative alla messa a disposizione sul mercato di apparecchiature radio e che abroga la direttiva 1999/5/CE

• Direttiva 2011/65/UE del Parlamento Europea e del Consiglio dell’8 giugno 2011 sulla restrixione dell’uso di determinate sostanze pericolose nelle apparecchiature elettriche ed elettroniche

• Direttiva 2014/30/UE del Parlamento Europeo e del Consiglio del 26 febbraio 2014 concernente l’armonizzazione delle leislazioni degli Stati member relative alla compatibilità elettromagnetica

• Direttiva 2014/35/UE del Parlamento Europeo e del Consiglio del 26 febbraio 2014 concernente l’armonizzazione delle legislazioni degli Stati membri relative alla messa a disposizione sul mercato del materiale elettrico destinato a esser adoperato entro tauni limiti di tensione

e come tale il prodotto porta il marchio CE. Firmato a nome e per conto di LumiraDx Inc:

Firmare

Name Dorian LeBlanc

Title CFO

Date (YYYY-MM-DD) 2019-05-24

Appendice A

Elenco di Standard Armonizzato usato EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

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1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Norwegian

Document Number: W-QMS-FRM-40037 Revision: 1 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

most recent version unless formally issued and stamped by QA. Created with C-QMS-TEM-00001 R.2

EK-OVERENSSTEMMELSESERKLÆRING (NO)

Vi LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America

herved erklærer vi på eget ansvar et produktet,

Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

som denne erklæringen vedrører, er is samsvar med de harmoniserte standarder og soesifikasjoner som er oppført i vedlegget, og følgende europeiske direktiver som omsettes i mediemslandenes nasjonale lover:

• Europa-Parlamentets og Rådets Direktiv 2014/53/EU av 16. April 2014 om harmonisering av medlemsstaternes lovgivning om tilgjengeliggjøring på markedet av radioutstyr og opphevelse av direktiv 1999/5/EF

• Europa-Palamentets og Rådets Direktiv 2011/65/EU av. 8 juni 2011 om begrensning av bruken av visse farlige stoffer i elektrisk og elektronisk utstyr EØS-relevant tekst

• Europa-Parlamentets og Rådets Direktiv 2014/30/EU av 26 februar 2014 om harmonisering av medlemsstaternes lovgivning om elektromagnetisk kimpatibilitet

• Europa-Parlamentets og Rådets Direktiv 2014/35/EU av 26 februar 2014 om harmonisering av medlemsstaters lovgivning om tilgjengeliggjøring på markedet av elektrisk utstyr konstruert for bruk innenfor visse spenningsgrenser

og som sådan bærer produktet CE-merket.

Signert for og på vegne av LumiraDx Inc:

Tegnet

Navn Dorian LeBlanc

Tittel CFO

Dato (YYYY-MM-DD) 2019-05-24

Blindtarm A List over Harmoniserte Standarder brukte

EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013

Page 9: EC DECLARATION OF CONFORMITY (EN) - LumiraDx...1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Danish Document Number: W-QMS-FRM-40035 Revision: 1 This document

1 of 1 Document Name: LumiraDx Connect Hub Declaration of Conformity - Swedish

Document Number: W-QMS-FRM-40029 Revision: 3 This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

most recent version unless formally issued and stamped by QA. Created with W-QMS-FRM-40029 R.2

EG-FÖRSÄKRAN OM ÖVERENSSTÄMMELSE (SV)

Vi: LumiraDx Inc 221 Crescent Street Waltham MA 02453 United States of America

intygar på eget ansvar att den produkten Product Name: LumiraDx Connect Hub Identifier: 720-10002-01

som denna declaration ovser, överensstämmer med de harmoniserade standarder och specifikationer som anges I bilagan och följande europeiska direktiv som införivats I medlemsstaternas nationella lagstiftning:

• Europapalamentets ich Rådets Direktiv 2014/53/EU av den 16 april 2014 om harmonisering av medlemsstaternas lagstiftning om tillhandahållande på marknaden av radioutrustning och om upphävande av direktiv 1999/5/EG

• Europarlamentets och Rådets Direktiv 2011/65/EU av den 8 juni 2011 om begränsning av användning av vissa farliga ämnen i elektrisk och electronisk utrustning

• Europaparlamentets och Rådets Direktiv 2014/30/EU av den 26 februari 2014 om harmonisering av medlemsstaternas lagstiftning om elektromagnetisk kompatibilitet

• Europaparlamentets och Rådets Direktiv 2014/35/EU av den 26 februari 2014 om harmonisering av medlemsstaternas lagstiftning om tillhandahållande på marknaden av elektrisk utrustning

Och som sådan har produkten CE-märket. Tecknat för och på uppdrag av LumiraDx Inc: Signerad

Name Dorian LeBlanc

Title CFO

Date (YYYY-MM-DD) 2019-05-24

Bilaga A

Lista över Harmoniserad Standard begagnade

EN 300 328 V2.1.1 (2016-11) EN 55011: 2009 / A1: 2010 EN 61326-2-2: 2013 EN 61326-2-3: 2013