Laerdal Medical AS

Laerdal Medical AS produces a range of resuscitation and monitoring devices, including single-use and reusable products. Their portfolio covers face shields in multiple languages, silicone resuscitation masks, manometers for bag-valve devices, and fetal/neonatal heart rate monitors like the Moyo and NeoBeat Sys. They also offer airway management tools such as the Stifneck and reusable silicone masks, designed for both emergency and clinical use.

Laerdal Medical AS is headquartered in Norway. Their devices are authorised in multiple markets, including the European Union (where they appear in the EUDAMED database) and the United States (where some devices require FDA 510(k) clearance). The company’s product classifications under EU Medical Device Regulations span Class I, Class II, Class IIa, and Class IIb, reflecting varying risk levels and regulatory requirements.

Laerdal Medical AS’s devices are listed in the EUDAMED database for European Union market authorisations. Additionally, some of their products are subject to FDA 510(k) clearance in the United States, meaning they appear in the FDA’s 510(k) registry. These registries reflect the regulatory pathways required for device authorisation in those regions.

Laerdal Medical AS’s devices are classified under the EU Medical Device Regulations into four categories: Class I (low-risk devices like some single-use face shields), Class IIa (moderate-risk items such as certain resuscitation masks), Class IIb (higher-risk products like fetal heart rate monitors), and Class II (devices requiring stringent controls, such as some manometers). Classification depends on factors like intended use, duration of contact with the body, and potential health risks.

The FDA’s 510(k) clearance process applies to medical devices in the United States that are deemed substantially equivalent to a legally marketed predicate device. Laerdal’s devices requiring this pathway—such as certain resuscitation tools or monitors—must demonstrate safety and performance comparable to existing FDA-authorised products. This ensures compliance with U.S. regulatory standards before market entry, as the FDA does not grant approvals for devices but evaluates equivalence to prior cleared products.