EU → North America Device Access

Laerdal Medical AS

NO-MF-000000012 · Norway · Stavanger

Laerdal Medical AS is registered in the European database on medical devices as a manufacturer, with 263 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa263

Most frequent device types declared: Full covering Carrying, Bag LSU, LSU w/Serres Suction Bag, Eastern Europe, Laerdal Disp. Mask #2, w/inflation port, Laerdal Face Shield, Laerdal Silicone Mask.

Among these devices, 28 are declared active.

Devices declared under this manufacturer

Showing 12 of 263 declared devices.

Catalogue references include 46000002, 46000015, 469900, 78003057, 78240040, 846141.

European nomenclature codes declared: R03010199, R03020199, R030280, R03020201, R0599, R030180.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryLAERDAL MEDICAL A/S (NO) · FDA 9610483
Devices in EUDAMED263
Country of registrationNorway

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

Device-level evidence

Devices with a numeric GTIN263
Found in the U.S. device database95
Share36.1 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryLAERDAL MEDICAL AS

What it holds in Canada

Licences on record9
Currently active0
Class 2 devices9
First licensed2000-04-05

Licence types: Device Family (4), System (3), Single Device (1), Device Group Family (1).

Licensed under: LAERDAL SILICONE RESUSCITATOR, LAERDAL POCKET MASK, LAERDAL SUCTION UNIT, LAERDAL SILICONE RESUSCITATOR MASK, THE BAG II DISPOSABLE RESUSCITATOR, LAERDAL POCKET MASK.

Notified body certificates

CertificateStatusExpiry
10000470903-PA-NoMA-DNKissued2026-11-19

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