EU → North America Device Access

Laboratoires URGO HEALTHCARE

FR-MF-000001538 · France · Dijon

Laboratoires URGO HEALTHCARE is registered in the European database on medical devices as a manufacturer, with 218 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa218

Most frequent device types declared: URGO DISCREET (box of 20 dressings), URGO Damaged nails, filmogel, URGO EXTENSIBLE, URGO LAVABLE (X10 bandes à découper), URGO SOS Coupures, bande auto-adhérente.

Among these devices, 13 are declared sterile, 17 active.

Devices declared under this manufacturer

Showing 12 of 218 declared devices.

Catalogue references include 3664492000695, 3664492000770, 3664492001081, 3664492012308, 3664492018683, 3664492020860.

European nomenclature codes declared: H900299, M04010101, Q030103, M050101, M0499, M030299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED218
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN216
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Laboratoires URGO HEALTHCARE was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
10000452411-PA-NoMA-FRAissued2027-12-20

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