Which markets do CE, ISO and FDA apply to? Which certifications do you currently hold?

CE: EU 27 countries plus the European Economic Area. FDA: the United States. ISO 13485: a globally applicable quality system. We hold CE MDR, FDA and ISO 13485 - certificates are verifiable online, valid for 5 years, and cover our full first aid kit range.

Key points:

1. CE - EU 27 + EEA market access.

2. FDA - US market registration.

3. ISO 13485 - Global medical device quality system.

4. 5-year validity - Certificates valid 5 years, covering all kit series.

Ask us for the certificate list and verification links for your specific market.

Contact us for more details: Send Inquiry