EU → North America Device Access

Laboratoire Unither

FR-MF-000004062 · France · Amiens

Laboratoire Unither is registered in the European database on medical devices as a manufacturer, with 176 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa176

Most frequent device types declared: SoFarma SOLUZIONE ISOTONICA multiuso, Sterile hypertonic solution of sodium chloride 3% in vials for inhalat, Sterile hypertonic solution of sodium chloride 6% in vials for inhalat, Sterile hypertonic solution of sodium chloride 7% in vials for inhalat, Sterile isotonic solution of sodium chloride 0.9% in single-dose vial .

Among these devices, 176 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 176 declared devices.

Catalogue references include 2 105812 004869, 3 250391 300365, 3 468080 082953, 5 600954 004502, 5 947664 110124, 8 470002 243507.

European nomenclature codes declared: Q02030299,Q030103,Q03040299,R060203,V9099, Q02030299,Q030103, R0699, R060203.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLABORATOIRE UNITHER (FR) · FDA 3010162623
Devices in EUDAMED176
Country of registrationFrance

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryLABORATOIRES THEA

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record6
Currently active0
Class 2 devices6
First licensed2014-01-03

Licence types: Device Family (3), Single Device (3).

Licensed under: THEALOZ DUO, THEALOZ DUO GEL, BLEPHACLEAN, THEAHYABAK, THEALOZ GEL, THEALOZ TOTAL.

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