Regulatory Registrations
Lenstec, Inc is a FDA Registered Company and in 2010 received FDA Approval for Softec HD and Softec I followed by Softec HDO in 2011, Softec HDM in 2017 and ClearView 3 in 2022. Lenstec, Inc. is also an ISO 13485 company.
Please see the links below:
Documentation
Please see the links below:
Documentation
ISO 38446 Certificate | |
File Size: | 804 kb |
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CE Certificate | |
File Size: | 407 kb |
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MDR 756533 R000 | |
File Size: | 856 kb |
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MDR 756711 R000 | |
File Size: | 1144 kb |
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United Kingdom Labour Standards Policy
Please click the link below to view the Labour Standards Assurance Policy
Labour Standards Policy | |
File Size: | 184 kb |
File Type: |