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Certifications and regulatory compliance
LifeVac is a Class I medical device in accordance with EU Regulation (EU) 2017/745 (MDR) and UK MDR 2002, conforming to all applicable requirements for safety and performance:
- CE-marked under Regulation (EU) 2017/745
- UKCA-marked under UK MDR 2002
- FDA-registered as a Class II medical device in the United States
- HRA-registered for the United Kingdom
- Approved by Health Canada
- Registered in Australia (ARTG / TGA), Brazil (Anvisa), South Africa (SAHPRA), and Taiwan (TFDA / MOHW)
- Manufactured under ISO 13485 certified quality management systems
Manufacturing and quality assurance
Each LifeVac unit is manufactured in the European Union (primarily in the UK for the EMEA region).
Every single unit is individually tested at the factory to ensure proper suction, valve integrity, and material reliability before packaging.
Local authorizations
The company Nuvolina SRL is registered as an authorized importer of the LifeVac device with the National Agency for Medicines and Medical Devices of Romania (ANMDMR) and holds authorization no. 314 issued on April 3, 2025.