EU → North America Device Access

IMMUNOTECH SAS

FR-MF-000011121 · France · MARSEILLE CEDEX 9

IMMUNOTECH SAS is registered in the European database on medical devices as a manufacturer, with 295 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Most frequent device types declared: A48571, B13127, B13129, B52699, B63284.

Devices declared under this manufacturer

Showing 12 of 295 declared devices.

Catalogue references include A07771, A07778, A07787, A07803, B36286, B36291.

European nomenclature codes declared: W0103080199, W0103080499, W0103080699, W0103080299, W01020410, W01030803.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryIMMUNOTECH s.r.o. (CZ) · FDA 3003385757
Devices in EUDAMED295
Country of registrationFrance

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

Device-level evidence

Devices with a numeric GTIN295
Found in the U.S. device database18
Share6.1 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryIMMUNOTECH S.R.O.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record14
Currently active0
Class 2 devices14
First licensed2005-04-08

Licence types: Test Kit (13), Device Family (1).

Licensed under: ULTRA-SENSITIVE ESTRADIOL RIA, ACTIVE IGFBP-3 IRMA, DEHYDROEPIANDROSTERONE (DHEA) RIA, ACTIVE ANDROSTENEDIONE RIA, ACTIVE ALDOSTERONE RIA, ESTRONE RIA.

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