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Regulatory
Medical Devices Regulation (MDR)
All DermLite devices conform to the Medical Devices Regulation (EU) 2017/745 (MDR), and we are registered as a manufacturer with EUDAMED under SRN US-MF-000005170.
Authorized Representative
ECREP LIMITED
SRN: IE-AR-000003995
5 Fitzwilliam Square East
Dublin, D02 R744
Ireland
Tel: +353 89 225 1951
Certificates & Registrations
- CE Certificate 2023-2024 (dated 1 March 2024)
- EU MDR Certificate of Conformity (dated 18 May 2023)
- UK Certificate of Conformity (dated 18 May 2023)
- US FDA Establishment Registration & Device Listing
- Declaration of Conformity MedDO (Switzerland, dated 18 May 2023)
- Certificate to Foreign Government (dated May 30, 2023)
- ISO 13485:2016 Certificate (dated 30 Dec 2023)
- DermLite Code of Conduct (dated 31 August 2023)
Resources
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