Production Enterprise Platform

What is UDI

Medical Device Identification（UDI "refers to a code consisting of numbers, letters, or symbols attached to medical device products or packaging, used for sexual identification of medical devices. Adopting a unified and standardized UDI globally is beneficial for improving supply chain transparency and operational efficiency, reducing operating costs, achieving information sharing and exchange, monitoring adverse events and recalling problematic products, improving medical service quality, and ensuring patient safety.

GS1 UDIProduction Enterprise Platform

UDI label and printing

·standardizationUDI tag templates can be flexibly called and data can be automatically filled in;

·Custom tag component-based operation, self-service editing does not require customization;

·Batch download of UDI data, direct reading printing by the printer mechanism;

·manual/Fully compatible with automatic printing equipment;

·Automated printing equipmentAPI integration.

UDI encoding and coding
·No need to form a coding team, automate and self allocate compliance for medical device productsDI code;

·Connect with the National Medical Products AdministrationUDI database, supports one click submission to the database, and also opens API interfaces for integration with enterprise ERP;

·conveniencePI information management, guided operation does not require training or learning;

·Independent traceability value range control, using traceability data to connect various links of production, storage, transportation, and distribution terminals;

·One click dual synchronization, compliant filing of drug regulatory database and China commodity information service platform, meeting the requirements of drug regulatory authorities and market supervisionRegulations on the Filing of Product Information in the Bureau;

·The system supports setting up operational roles, with dedicated personnel managing DI/PI separately;

·Complete the entire UDI coding process with "low cost, fastest speed, and simplest operation".

UDI Implementation Consulting

·Publish and follow up on policy and related conference news content in a timely manner;

·The UDI implementation guidelines are updated online, and regular training on medical device coding is held. The * * department interprets policies, regulations, and standards;

·Provide one-on-one consulting services for registered enterprises;

·Dedicated customer service provides professional answers for the entire process of UDI implementation.

UDI Enterprise Database

·Thoroughly implement the requirements of the Drug Administration for standardized storage and convenient access of UDI data, and build a private UDI database for enterprises to facilitate data access and ensure data security;

·Provide for every enterpriseUDI data storage capability;

·supportUDI data download, high scalability to meet system level integration on enterprise ERP, MES, and other related platforms;

·Connect the database of the drug regulatory bureau to ensure that products are called up as quickly as possible during circulationUDI data;

·Scan the QR code in the mini program to check the product registration status.

UDI Omnichannel Application

·Supply chain visualization, with the function of tracking and tracing product circulation links, completes the entire data chain from internal management and shipment to product usage;

·Automatic dual filing of drug supervision and market regulation, and full channel sharing of product information online/logistics;

·Manufacturer identity globally recognized.