The scope is to cover Blood Collection Sets, Blood Collection Needles (Safety and Standard), Blood Culture Systems with Initial Specimen Diversion Device, Blood Culture Bottles, Blood Culture Packs, Blood Sample Tubes, Blood Gas Syringes, Support Products, and Associated Products.
I need to see your factory certificates:
-ISO,
-Declaration of Conformity,
-EN Certificates
-CE/MDR
Read the specification and see which lot you have products for.