CMR/Endocrine

Hier können die UDI-DI spezifischen Informationen zu "CMR/Endocrine" hinterlegt werden.

Category of CMR und Name of Substance sind Pflichtfelder. Wurde kein EC code oder CASC code angegeben, müssen die Übersetzungen von Name of Substance für alle Sprachen angegeben werden, wo die Kennzeichnung verwendet wird. Die Angabe der Übersetzungen liegt in der Verantwortung vom Anwender.


Weitere Informationen sind unter Stammdaten UDI beschrieben.


Verwendung dieses Programms

Felder

Überschriftsformat

Feldbezeichnung Erklärung
Basic UDI-DI Device Identified code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.). The Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the 'access key' to information stored in a UDI database. The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
Primary DI Number
The Primary Device Identifier (DI) is the DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements.  If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent.   The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use.

CMR/Endocrine

Feldbezeichnung Erklärung
Category of CMR When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances. Field stores the details regatrding the type of Substance registered (CMR Substance / Endocrine substance/ Substance which can be considered a Medicinal Product or Substance which may be considered a medicinal product derived from human blood or plasma).
Name of Substance When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances. Field stores the Name of Substance (applicable for all types of substances - CMR, Endocrine , Medicinal product, Medicinal product derived from human blood or human).
EC code When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances. Field Stores the EC Code (EC#)associated to the CMR or Endocrine disrupting substance. EC# can be provided only for CMR or Endocrine-disrupting substances.
CAS code When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances. Field stores the CAS Code (CAS#) associated to the CMR or Endocrine disrupting substance. CAS# can be provided only for CMR or Endocrine-disrupting substances.

  • Keine Stichwörter