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EU: CE MDR with strict classification, technical file and EU Authorised Representative. US: FDA registration and labeling rules. Germany: DIN standard configurations such as DIN 13164. UK: UKCA, an independent certification after Brexit.
Key points:
1. EU market - CE MDR, technical file plus EU Representative, EUDAMED registration.
2. US market - FDA registration, consumable registration and labeling rules.
3. German market - DIN 13164 fixed configurations for vehicle first aid kits.
4. UK market - UKCA independent certification after Brexit.
Our multi-certification compatible design lets one kit configuration satisfy several countries at the same time.
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