Manufacturer’s Periodic Summary Report (PSR) Form


1. Administrative information

2. Information on submitter of the report

3. Manufacturer information
4. Authorised Representative information
5. Submitter´s information (if different from section 3 or 4)
6. Medical device information

7. PSR Information

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8. Manufacturer's comments / investigation results
9. Distribution

The medical device has been distributed to the following countries

Within EEA, Switzerland and Turkey