The medical device or IVD register must, in respect of a registered medical device or IVD, contain the following information:
| (a) | The name and group or family and the make and model, where applicable, of the medical device or IVD; |
| (b) | the registration number allocated to the medical device or IVD; |
| (c) | in the case of a combination device, the name and quantity of the scheduled substances or biological substances in the medical device; |
| (d) | the intended purpose or use of the medical device or IVD; |
| (e) | the name of the holder of the certificate of registration; |
| (f) | the name and address of the original manufacturer; |
| (g) | the date of registration of the medical device or IVD; |
| (h) | the conditions of registration of the medical device or IVD; |
| (i) | the class of medical device or IVD; and |
| (j) | the nomenclature system code allocated to the medical device or IVD. |
