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Supporting bandages, with or without reinforcements, provide the surface to be treated with the support necessary for the treatment of the trauma.
Custom-made device declaration cf. annex XIII Medical Devices Regulation 2017/745 EEC
Manufacturer: Laboratoria Bota nv, established in Belgium, 9800 Deinze, Stadionlaan 12
declares that the above mentioned medical device with article number and lot number is exclusively intended for use by a specific patient with patient identification:
and has been prescribed by a qualified practitioner as listed below:
Specific features of the medical device as indicated in the prescription: custom made.
Manufacturer declares that the medical device identified above is in conformity with the general safety and performance requirements in Annex I of the Medical Device Regulations 2017/745 EEC.
Made to measure, no returns possible.
Deinze, date of invoice.
Philippe Moerkens.
CEO
Laboratoires Bota NV