In accordance with the Personal Protective Equipment Regulation (EU) 2016/425 ANNEX IV INTERNAL PRODUCTION CONTROL (Module A) declares on his sole responsibility that the PPE concerned satisfies the applicable requirements of this Regulation.
Manufacturer:
Reef MedicalManufacturer’s Address:
P.O. Box. 230412 Encinitas, CA 92023Tel:
+353 +353 89 225 1951Responsible Person in the European Community:
E.C Rep Ltd, 5 Fitzwilliam Square East, Dublin 2, D02 R744, IrelandTel:
+353 +353 89 225 1951Email:
+353 +353 89 225 1951VAT Number:
3645609VHResponsible Person in the European Community:
E.C Rep Ltd, 5 Fitzwilliam Square East, Dublin 2, D02 R744, IrelandTel:
+353 +353 89 225 1951Email:
+353 +353 89 225 1951VAT Number:
3645609VHProduct:
Eye Shields (non-sterile)Description:
Protective EyewearProduct Class:
Self DeclarationDeclaration of Conformity
The Designated Representative of the Manufacturer declares that the PPE described above is in conformity with the provisions of Personal Protective Equipment Regulation (EU) 2016/425, EN 166, and other appropriate standards, that the manufacturer has duly complied with the applicable Annexes and in accordance with Article 3, 8, 16 and 17 applies the CE Mark by Self Declaration.
Signed by Reef Medical LLC’s designated representative:
Daniel Bajek
Manufacturer's Representative
3/24/2024
