The use of GMDN codes for IVD medical devices in Australia
(the Regulations) states that for the purposes of section 41BE (1) (e) of the Act, a characteristic for Class 4 IVDs, other than Class 4 immunohaematology reagents (Class 4 IHRs), is the unique product identifier (UPI) given to the device by its manufacturer to identify the individual device type and any variants. ................
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