Do your first aid kits have CE certificates? (Standard reply)

Under EU MDR (EU) 2017/745, non-EU based suppliers selling products into the EU must meet the following requirements: Non-sterile Class I devices need a CE Declaration of Conformity (DoC) plus EU Authorised Representative plus EUDAMED registration - Notified Body certification is not required. Sterile Class I devices need a CE certificate from a Notified Body plus DoC plus EU Authorised Representative plus EUDAMED registration. First aid kits under Article 22: non-sterile kits do not require a Notified Body CE certificate - only a manufacturer-issued Statement (similar to a DoC) plus EUDAMED registration. Our company has obtained and fully complied with all the above qualification requirements.

Key points:

1. Non-sterile Class I - CE DoC + EU AR + EUDAMED registration; no Notified Body certificate.

2. Sterile Class I - Notified Body CE certificate + DoC + EU AR + EUDAMED registration.

3. First aid kits (Art. 22) - Manufacturer Statement + EUDAMED registration; no Notified Body certificate.

4. All obtained - Our company holds all required qualifications.

Contact us and we will share the specific CE documentation applicable to your configuration.

Contact us for more details: Send Inquiry