b+b trace UDI Software
b+b trace UDI Software provides serialization for medical devices to support implementation of the Medical Device Regulation at level 3.
What b+b trace UDI Software is
b+b trace UDI Software provides serialization for medical devices to support implementation of the Medical Device Regulation at level 3. It lets users create, edit, and import work or process orders, then report traceability information to multiple markets, customers, and databases. Its modules cover users and rights, audit trails, customers and target markets, items, production lines, interfaces, and label layouts. Site management includes aggregation hierarchies, reworking, and sampling; serial number management is optional. The multipack manager can combine items across GTINs and aggregate them to a new serial number. ERP and Level 5 (EUDAMED) interfaces are available, and the line manager is a Level 2 component for parameterizing and controlling line components. The SiteServer can run on-premise or in the cloud, but customers provide a Windows VM and MS SQL Server database. The company lists contract manufacturers and brand owners as intended customers. Pricing is on request; tailored support contracts are available, with priority support and free updates for customers while an SLA is valid.
Good
- Reports traceability to multiple markets and databases
- Supports aggregation across GTINs
- Includes ERP and EUDAMED interfaces
- SiteServer can run on-premise or in the cloud
Watch out
- Pricing is available on request
- Customer supplies a Windows VM and MS SQL Server database
- Serial number management is optional
Who it suits
It suits medical-device contract manufacturers and brand owners that need serialization, traceability reporting, and aggregation. Customers must provide a Windows VM and MS SQL Server database.
Verdict
b+b trace UDI Software combines work-order handling, serialization, aggregation, and traceability reporting for medical-device production. Check the infrastructure requirements and request pricing before choosing it.
The facts
Each one read from b+b trace UDI Software's own pages, with the date it was checked.
What it does
- Aggregation
- The multipack manager can create cross-GTIN multipacks and aggregate them to a new serial number.checked 9 Oct 2026
- Audit trail
- The maker describes the audit trail as similar to CFR 21 Part 11.checked 10 Oct 2026
- Database access
- b+b provides the SQL Server database table structures, and the customer receives read access to table data.checked 10 Oct 2026
- ERP integration
- The b+b ERP link provides an interface to the customer's ERP system.checked 10 Oct 2026
- EUDAMED integration
- The b+b repository link provides an interface to Level 5 (EUDAMED).checked 10 Oct 2026
- Hosting and requirements
- The SiteServer can run on-premise or in the cloud, and the customer provides a Windows VM and MS SQL Server database.checked 9 Oct 2026
- Infrastructure
- The customer provides a Windows VM and MS SQL Server database; the SiteServer can run on-premise or in the cloud.checked 10 Oct 2026
- Integrations
- The listed modules include an ERP interface and a repository interface to Level 5 (EUDAMED).checked 9 Oct 2026
- Intended customers
- The maker says its tailored solution serves contract manufacturers and brand owners.checked 10 Oct 2026
- Line control
- The b+b line manager is a Level 2 component for parameterizing and controlling line components.checked 10 Oct 2026
- Management features
- Modules include user and rights management, audit trails, customer and target market management, item management, line management, interface management, and label layout management.checked 9 Oct 2026
- Purpose
- The software supports serialization in medical technology for implementing MDR requirements at Level 3.checked 10 Oct 2026
- Reporting
- The software can report to multiple markets, customers, or databases.checked 10 Oct 2026
- Serial number management
- Serial number management is listed as optional.checked 9 Oct 2026
- Support
- The company lists a service phone number and a support request option on its software modules page.checked 10 Oct 2026
- Traceability features
- The site manager includes aggregation hierarchy management, serial number management, reworking, and sampling.checked 10 Oct 2026
- Traceability reporting
- The software supports reporting to multiple markets, customers, and databases.checked 9 Oct 2026
- User controls
- Available modules include user and rights management, with an audit trail in all modules.checked 10 Oct 2026
- Work orders
- Users can create, edit, and import work orders or process orders.checked 10 Oct 2026
The company
- Company
- b+b Automations- und Steuerungstechnik GmbH lists its address as Dieselstraße 18, 64760 Oberzent, Germany, and says it was founded in 1986 in Airlenbach.checked 10 Oct 2026
- Founded
- 2006checked 28 Sep 2026
- Headquarters
- Oberzent, Germanychecked 28 Sep 2026
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