Labtician Ophthalmics  

About Labtician

Certifications


Medical Device Establishment Licence

This Licence is issued by Health Canada to Labtician Ophthalmics and is applicable to the manufacturing of Risk Class I devices and the importation and distribution of licensed medical devices manufactured by foreign manufacturers for which Labtician Ophthalmics distributes in Canada.


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Drug Establishment Licence

This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to drug products manufactured by foreign manufacturers for which Labtician Ophthalmics imports and distributes in Canada.


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Cells, Tissues and Organs Establishment Licence

This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to the importation and distribution of minimally processed tissue products supplied by foreign manufacturers for which Labtician distributes in Canada.


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Natural Health Products Site Licence

This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to the importation and distribution of Natural Health Products manufactured by foreign manufacturers for which Labtician Ophthalmics imports and distributes in Canada.


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CE Mark Certificate

 

CE Mark (Annex II) Certificate

This certificate is issued by the British Standards Institute to Labtician Ophthalmics and grants market access to EC and EFTA countries, and covers medical devices manufactured by Labtician Ophthalmics that are classified as Risk Class IIa and higher.


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Certification of Registration

 

CE Mark (Annex V) Certificate

This certificate is issued by the British Standards Institute to Labtician Ophthalmics and grants market access to the EC and EFTA countries, and covers medical devices manufactured by Labtician Ophthalmics that are classified as Risk Class I, Sterile.


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ISO Certificate

 

ISO 13485 Certificate

This certificate is granted by the British Standards Institute to Labtician Ophthalmics on the basis of Labtician Ophthalmics continuing compliance to the ISO 13485 Quality Management System standard. This standard applies specifically to medical devices manufactured by Labtician Ophthalmics.


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FDA Certification

 

FDA Establishment Registration (USA)

Labtician Ophthalmics maintains their annual Establishment Registration with the USA’s Food and Drug Administration, covering products manufactured by Labtician Ophthalmics and sold in the USA.