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The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components. These provide access to useful information about the device.
A identificação única do dispositivo (UDI) é um código numérico ou alfanumérico único relacionado com um dispositivo médico. Permite uma identificação clara e inequívoca de dispositivos específicos no mercado e facilita a sua rastreabilidade. A UDI inclui os seguintes componentes: Um identificador único do dispositivo (UDI-DI); Um ...
Einmalige Produktkennung (Unique Device Identifier – UDI) Die UDI ist ein eindeutiger numerischer oder alphanumerischer Code für ein Medizinprodukt. Sie ermöglicht eine klare und eindeutige Identifizierung spezifischer, auf dem Markt befindlicher Produkte und erleichtert deren Rückverfolgbarkeit. Die UDI umfasst folgende Komponenten:
UDI/Device registration. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce a device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information ...
Registo UDI/Dispositivos. O Regulamento (UE) 2017/745 relativo aos dispositivos médicos e o Regulamento (UE) 2017/746 relativo aos dispositivos médicos para diagnóstico in vitro introduzem um sistema de identificação de dispositivos da UE baseado no identificador único do dispositivo (UDI) que facilita a rastreabilidade dos dispositivos ...
Jedinečná identifikace prostředku (UDI) je jedinečný číselný nebo alfanumerický kód vztahující se ke zdravotnickému prostředku. Umožňuje jasnou a jednoznačnou identifikaci konkrétních prostředků na trhu a usnadňuje jejich vysledovatelnost. UDI se skládá z: Ty poskytují přístup k užitečným informacím o prostředku.
UDI assignment and placing the UDI-carrier on the label where required. Therefore, in the above case, the distributor, assuming the obligations of the manufacturer will have to assign a new Basic UDI-DI to devices sold under its name, registered trade name or registered trademark. This means that the distributor
Guidance on basic UDI-DI and changes to UDI-DI: April 2021: MDCG 2020-18: MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers: December 2020: MDCG 2019-2: Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017: February 2019: MDCG 2019-1
evice identification and coding standard. It allows the unambiguous identification o. a specific medical device on the market. The. DI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be. duction of a UDI comprises the following:• A UDI device identifier (‘UDI-DI ...
16 de dez. de 2022 · The EUDAMED Information Centre is the central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentation. The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.
