Creating REF number for medical device

[Billy Milly]

Look into UDI requirements. It is not exactly what you are asking directly, but you can draw some parallels (1 UDI = 1 REF, 1 basic UDI = 1 family).

In the case you described above, product names would be "analysis 1 BCP" and "analysis 2 BCP". Each with a different indication (why would you need different kits, if not to address a diffrent need?).

 

[MarRz]

I checked and generated UDI as:
basic UDI - family for all blood collection packages
UDI-DI - connected to REF
UDI-PI - more details of the device based on LOT and expiry date

Regarding the product names, from my previous post, the kits have the same purpose. But are used for different products. Different products mean how the blood will be later analysed. The product name here, is only so that user know specifically which analysis he will get. It is not a medical device.

The function of kit/package (medical device in this case) does not change even if connected to different product name (analysis). That is why I am thinking of having only one registered. The blood can be used for different analyses, hence the different names of the products on the box. Still, this does not affect blood storage and transport (the intended purpose of the package/medical device).

This is what I am unsure of, if it is correct to make this kind of "combinations".