EUDAMED (UDI data), GDSN data registration service
EUDAMED (UDI data), GDSN UDI data registration service
We provide UDI databases including EUDAMED and GDSN data registration services to medical device manufacturers.
The "BYRD - theplatform" provided by the German company osapiens/BYRD.health is a service that supports the registration and transmission of UDI data such as MDR, IVD-R, MDD, and IVD-D to the medical device database "EUDAMED" (European Databank On Medical Devices) operated by the European Commission. In addition to the EU, we also provide data transmission services to the US FDA/GUDID, UK NHS/Scan4Safety, China NMPA/CUDID, Taiwan (TUDID), South Korea (IMDIS), and Saudi Arabia (SAUDI-UDI). Furthermore, we are planning to support UDI data submissions for countries such as Australia, Switzerland, Canada, Brazil, and Egypt in the future. Grid Agent offers this service to medical device manufacturers in Japan and the Asia-Pacific region.
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basic information
EUDAMED uses DTX connection (data transmission via access point), while GUDID employs HL7 SPL connection (data transmission via ESG account). Transmission via GDSN connection method from a GDSN certified data pool is also possible (if the data recipient specifies GDSN as the transmission method).
Price information
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Delivery Time
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Applications/Examples of results
Main Users ○ All manufacturers selling medical device products overseas ○ It can be used in departments such as production technology, manufacturing, quality control and regulatory affairs, logistics, sales and marketing, and master data management. ● For detailed information about the EUDAMED registration service and its implementation, please contact our sales headquarters directly at the email below. Email: healthcare@gridagent.co.jp
Detailed information
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EUDAMED UDI registration supports submission through a method of data exchange using XML file data called DTX (Data Exchange), which connects servers for data exchange. The product information of your company, centrally managed in the DTX database, can be reused for common data items not only in EUDAMED but also in other countries' databases. Additionally, by establishing a unified registration procedure, we significantly reduce the workload related to UDI submission and provide an environment that can be managed at a low cost.
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Company information
Grid Agent Co., Ltd. was established in May 2020, changing its name from the former NeoGrid AP Co., Ltd. It serves as an agent responsible for sales and support in the Asia-Pacific region for Neogrid, which provides supply chain solutions covering strategic sourcing and distribution, and for BYRD.Health GmbH, a German company that offers GDSN-compliant global product information management solutions. Additionally, it acts as a partner providing customer support for 1WorldSync in the Asia region. Through the solutions offered by Grid Agent, users can expect the following benefits: - Significant reduction in procurement costs - Accurate maintenance of optimal inventory levels to maximize profits - Streamlining of business processes - Strengthening of internal controls and compliance The solutions from Neogrid, BYRD.Health, and 1WorldSync are provided as SaaS model services built within a robust security environment, enabling companies to efficiently enhance their competitive edge in a short period.