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European Medical Device Directive 93/42/EEC

B Medical Systems S.á r.l. successfully passed the certification audit according to the harmonized European Quality Management System Standard for Medical Devices EN ISO 13485 and the European Medical Device Directive 93 / 42/ EEC.

All medical devices manufactured by B Medical Systems S.á r.l. will be labeled with the CE-Label (CE 0499). The product in question concerns blood product cooling devices / blood bank refrigerators. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.

Our medical device products will be all blood banks refrigerators from our range BR, as well as all plasma freezers from our ranges FR & MF.