Quality & compliance

Certificates

Our products are manufactured under accredited quality systems and certified for international markets.

  • CE markedEuropean conformity for medical devices
  • US FDA registeredRegistered manufacturing establishment
  • ISO 13485:2016Medical device quality management
CE Certificate

Fluorescein Strips

EU conformity certificate covering our ophthalmic diagnostic strips.

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CE Certificate

Sterile Disposable Medical Devices

EU conformity certificate covering sterile single-use ophthalmic devices.

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Quality System

ISO 13485:2016

Quality management system certification for the design and manufacture of medical devices.

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Notified Body

Confirmation letters

Notified Body confirmation of certification status.

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US FDA

Establishment registration

Registered medical device manufacturing establishment.

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