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