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A.MENARINI diagnostics

A.MENARINI diagnostics

A.MENARINI diagnostics

Product catalog summary
Declaration of Conformity Overview:
A. Menarini Diagnostics S.r.l., based in Florence, Italy, declares that their blood glucose measuring meters for self-testing conform to the Radio Equipment Directive 2014/53/EU. This declaration covers products such as GlucoMen® areo 2K, GlucoMen® areo, GLUCOFIX® TECH 2K, and GLUCOFIX® TECH.

Conformity Details:
The products comply with essential requirements of the directive, including safety and health (Article 3.1a), electromagnetic compatibility (EMC, Article 3.1b), and radio spectrum efficiency (Article 3.2). The frequency band used is 13.56MHz with varying maximum power outputs for different models.

Standards Applied:
The products adhere to several standards, including IEC 62368-1:2014, EN 62368-1:2014+A11:2017, EN 62479:2010, EN 301 489-1 V2.1.1, EN 301 489-3 V2.1.1, EN 60601-1-2:2007+AC:2010, EN 61326-1:2013, EN 61326-2-6:2013, and EN 300 330 V2.1.1.

Signature and Date:
The declaration is signed by Dr. Marco Di Carlo, Proxy and Legal Representative, on November 10, 2017.

Company Information:
A. Menarini Diagnostics S.r.l. operates under the direction of A. Menarini Industrie Farmaceutiche Riunite S.r.l. and has a presence in multiple countries including Austria, Belgium, France, Germany, Greece, the Netherlands, Portugal, Spain, Sweden, Switzerland, and the UK.
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Catalog excerpts

A.MENARINI diagnostics-1

A.MENARINI diagnostics DECLARATION OF CONFORMITY (Directive 2014/53/EU) Manufacturer A. Menarini Diagnostics S.r.l. Via Sette Santi 3 50131 Firenze, Italy Product Category according to Directive 98/79/EC for in vitro diagnostic medicai devices Blood giocose measuring meter for self-testing Description Product Name Blood Giocose Meter GlocoMen® areo 2K, GlocoMen® areo, GLUCOFIX® TECH 2K, GLUCOFIX® TECH, (any serial number) We hereby declare onder oor sole responsibility that the prodocts are in conformity with Directive 2014/53/EU of the Eoropean Parliament and of the Cooncil of 16 Aprii 2014 (and its relevant transposition into the national laws of the Member States in which the device is intended to be placed on the market) relating to the making available on the market of radio eqoipment. Conformity assessment route: Annex II applied (Directive 2014/53/EU) GlucoMen areo 2K Essential Requirements Radio Equipment Directive 2014/53/EU Safety & Health (Artide 3.1 a) Radio Spectrum Efficiency (Artide 3.2) Frequency Band(s): 13.56MHz Maximum power: 0.67 nW GlucoMen areo Essential Requirements Radio Equipment Directive 2014/53/EU Safety & Health (Artide 3.1 a) Radio Spectrum Efficiency Frequency Band(s); 13.56MHz Maximum power: 0.0077 mW Page 1 out of 2 A. MENARINI DIAGNOSTICS S.R.L - CAPITALE SOCIALE € 30.000.000 I.V. - SOCIETÀ' CON SOCIO UNICO - VIA SETTE SANTI, 3 - 50131 FIRENZE - TEL.055.56801 - C.P. 4063 - 50100 FIRENZE REG AEE N.IT08030000004131- C.F., P.I.V.A. E REG.IMPRESE FI 05688870483 - SOCIETÀ SOGGETTA ALL'ATTIVITA DI DIREZIONE E COORDINAMENTO DI A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L. - VIA SETTE SANTI. 3 - 50131 FIRENZE - P.l. 00395270481 - SEDE OPERATIVA : VIA LUNGO L'EMA, 7 - LOCALITÀ' PONTE A EMA - 50012 BAGNO A RIPOLI (FI) HEADQUARTERS - ITALY - EXPORT DIVISION: A. MENARINI DIAGNOSTICS S.r.l. - Firenze - AUSTRIA: A. MENARINI G.m.b.H. - Wien - BELGIUM: MENARINI DIAGNOSTICS BENELUX S.A./N.V.Zaventem - FRANGE: A. MENARINI DIAGNOSTICS FRANGE S.A.R.L, - Paris - GERMANY: A. MENARINI DIAGNOSTICS DEUTSCHLAND DIVISION DER BERLIN-CHEMIE AG - Berlin - GREECE; MENARINI DIAGNOSTICS S.A. - Athens - THE NETHERLANDS; MENARINI DIAGNOSTICS BENELUX N.V. - Valkenswaard - PORTUGAL: MENARINI DIAGNÓSTICOS LDA - Lisbon - SPAIN: A, MENARINI DIAGNOSTICOS S.A. - Badalona (Barcelona) - SWEDEN: A. MENARINI DIAGNOSTICS S.r.l. - Malmo - SWITZERLAND: A. MENARINI DIAGNOSTICS S.R.L. - Zùrioh - U.K.: A. MENARINI DIAGNOSTICS Lld. - W

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A.MENARINI diagnostics-2

A.M€NARINI diagnostics GLUCOFIX TECH 2K Essential Requirements Radio Equipment Dìrective 2014/53/EU Safety & Health (Artide 3.1a) Radio Spectrum Efficiency (Artide 3.2) Frequency Band(s): 13.56MHz Maximum power: 0.67 nW GLUCOFIX® TECH Essential Requirements Radio Equipment Dìrective 2014/53/EU Safety & Health (Artide 3.1 a) Radio Spectrum Efficiency (Artide 3.2) Frequency Band(s): 13.56MHz Maximum power: 0.0042 mW Signature: ^ ' v Dr. Marco Di Carlo Proxy and Legai Representative A. MENARINl DIAGNOSTICS S.R.L. - CAPITALE SOCIALE € 30.000.000 I.V. - SOCIETÀ'CON SOCIO UNICO - VIA SETTE SANTI, 3...

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.