Certificates

DEKRA 49289 EN ISO 13485 2016

Valid until 01-07-2027. Download the document.

DEKRA MDD CE Certificate IOLs 49290CE01

Valid until 01-07-2023. Download the document.

DEKRA MDD CE Certificate Disposables 49290CE02

Valid until 01-07-2023. Download the document.

DEKRA MDR CE Certificate HA & Silicone IOLs 2254207CE01

Valid until 01-11-2027. Download the document.

Note

The CE certificates under MDD (Directive 93/42/EEC) are expired on 1 July 2023. Due to regulation (EU) 2023/607, the CE marked products benefit from the extended transition period which means that our MDD certificate 49290CE01 (class IIb products) is extended until 31 December 2027 and our MDD certificate 49290CE02 (class IIa products) is extended until 31 December 2028. The CE marked products on these certificates may be placed on the market or put into service until these dates. A written self-declaration by OPHTEC BV and/or a confirmation letter written by DEKRA Certification BV, explaining the extension transition period, are available upon request at info@ophtec.com.