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A. MENARINI Diagnostics S.r.l.

Italy·IT-MF-000023427

Last updated June 8, 2026

About

A. Menarini Diagnostics s.r.l Via Sette Santi, 3 - 50131 Firenze (FI), ITALY Registration number in the Company House: 05688870483 Office of the Companies House: Firenze Share capital: € 30.000.000 I.V. Paid up capital: € 30.000.000 Company subject to the management and coordination of A.Menarini Industrie Farmaceutiche Riunite Srl

From the manufacturer's own website. Source

What A. MENARINI Diagnostics S.r.l. makes

A. Menarini Diagnostics produces in vitro diagnostic (IVD) devices for blood glucose monitoring, including self-testing sensors and control solutions. Their portfolio includes continuous glucose monitoring sensors (e.g., GlucoMen areo Sensor), ketone monitoring sensors (e.g., GLUCOFIX TECH B-Ketone Sensor), and glucose control strips (e.g., GLUCOFIX TECH GK). The company also manufactures reagent kits for molecular diagnostics, such as the Prime MDX PFP Extraction Kit for PCR-based testing.

These devices fall under Class A and IVD Annex II List B classifications, with some designated for self-testing. They are listed in the EU’s eudamed database, adhering to EU IVD regulations. The manufacturer is based in Italy, operating from its headquarters in Florence.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Italy
Address
3, Via Sette Santi, Firenze, Italy
Facebook
—
Phone
+393498538842
PRRC Contact
Lorenzo Polonia
EUDAMED SRN
IT-MF-000023427
FDA FEI Number
—
DUNS Number
—

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
GlucoMen areo Sensor 46182,46181,46184,46183,46192,46193,46191,46190,46189,46188,47948,48702,48704,48705,48706,48526, 48527,48528,48529,49198
EUDAMED
IVD Annex II List BActive
Glucofix Tech 46639 , 46634, 46635, 46636, 46637, 49573, 51344
EUDAMED
IVD Annex II List BActive
GLUCOFIX TECH Control 47686 FR/NL, 46630 FR/NL/IT/UK, 47687 FR/NL, 46631, FR/NL/IT/UK
EUDAMED
IVD Annex II List BActive
GlucoMen areo Control 46197,46199,46201,47954,46198,46200,46202,47955
EUDAMED
IVD Annex II List BActive
GLUCOFIX TECH B-Ketone Sensor 48726 NL, 49911 FR, 50404 FR-E, 50415 FR, 48583 IT, 57171 UK-IT-FR
EUDAMED
IVD Annex II List BActive
GlucoMen areo B-Ketone Sensor 48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,48821,48530,48531
EUDAMED
IVD devices for self-testingActive
GLUCOFIX TECH Sensor 46627 NL, 46626, 46623 FR, 46622 FR10,47688 FR 50, 48587 IT, 48586 IT10, 48585 IT25, 48584 IT, 51342 UK, 51343 UK
EUDAMED
IVD Annex II List BActive
GlucoMen areo 46203, 46211,46210, 46213, 49261, 48742, 46214, 46215, 46212
EUDAMED
IVD Annex II List BActive
Glucofix Tech Gk 52076 FR/IT, 52077 FR-basic, 52078 NL, 56815 UK, 57170 FR-basic-E, 57168 FR, 57169 FR-E
EUDAMED
IVD Annex II List BActive
GLUCOFIX TECH B-Ketone Control 48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555 (UK), 61556 (UK)
EUDAMED
IVD devices for self-testingActive
GlucoMen areo GK 54524, 52082, 52081, 52083, 61554, 61553,
EUDAMED
IVD Annex II List BActive
Prime MDX PFP Extraction Kit 2x24 rxn 56445
EUDAMED
Class AActive
SG Calibrator Set 31111
EUDAMED
IVD GeneralActive
OSMO Wash Solution 33350
EUDAMED
Class AActive
Aution wash solution 29072
EUDAMED
Class AActive
PRIME MDx DNA/RNA Extraction kit 2 x48 rxn 56446
EUDAMED
Class AActive

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