EU → North America Device Access

SENTINEL CH. S.p.A.

IT-MF-000012556 · Italy · Milano

SENTINEL CH. S.p.A. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Devices declared under this manufacturer

Catalogue references include 1156188, 17660, 550300, 550802, 6K89-20, 6K89-30.

European nomenclature codes declared: W0201010299, W01010301, W05019001, W0101050204.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entrySENTINEL CH. SPA (IT) · FDA 9681753
Devices in EUDAMED6
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database1
Share16.7 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entrySENTINEL CH. SPA

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record66
Currently active0
Class 2 devices65
Class 3 devices1
First licensed2007-02-19

Licence types: Test Kit (49), Device Family (11), System (3), Single Device (2).

Licensed under: ALINITY C FRUCTOSAMINE ASSAY, ALINITY C PANCREATIC AMYLASE REAGENT KIT, ALINITY C LAMBDA LIGHT CHAINS REAGENT KIT, ALINITY C HBDH REAGENT KIT, LIPASE NG OC ASSAY, ALINITY C CYSTATIN C.

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