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b+b trace UDI Software
Oberzent, Germany
What it is
b+b trace UDI Software provides serialization for medical devices to support Medical Device Regulation implementation at level 3. It is designed for contract manufacturers and brand owners, with work-order creation, editing, and import for production processes. The software reports traceability information to multiple markets, customers, and databases. Modules cover user and rights management, audit trails, customers and target markets, items, lines, interfaces, and label layouts. Site management includes aggregation hierarchies, reworking, sampling, and optional serial number management. A multipack manager can combine items across GTINs and assign a new serial number. Interfaces connect with a customer’s ERP system and Level 5 EUDAMED. The line manager is a Level 2 component for parameterizing and controlling line components. SiteServer can run on-premise or in the cloud, but customers provide a Windows VM and MS SQL Server database. b+b provides SQL Server table structures and read access to table data. Pricing is on request. Tailored support contracts are available, while SLA customers receive priority support and free updates during the SLA.
For and against
For
- Supports Medical Device Regulation level 3 serialization
- Work-order creation, editing, and import
- Aggregation and cross-GTIN multipack management
- ERP and EUDAMED interfaces
- Audit trails across modules
Against
- Pricing is available only on request
- Customer must provide Windows VM and MS SQL Server
- Serial number management is optional
- SLA benefits require an active SLA
The verdict
b+b trace UDI Software brings serialization, aggregation, reporting, and production-line controls into one modular system. Its customer-managed infrastructure and requested pricing make deployment planning important.
Who it suits
This software suits medical-device contract manufacturers and brand owners managing serialization, aggregation, traceability, and regulatory reporting. It is intended for Windows environments where the customer supplies the virtual machine and SQL Server database.
On the record
- Aggregation
- The multipack manager can create cross-GTIN multipacks and aggregate them to a new serial number.bb-trace.com · read 9 Oct 2026
- Audit trail
- The maker describes the audit trail as similar to CFR 21 Part 11.bb-trace.com · read 10 Oct 2026
- 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.bb-trace.com · read 10 Oct 2026
- Database access
- b+b provides the SQL Server database table structures, and the customer receives read access to table data.bb-trace.com · read 10 Oct 2026
- ERP integration
- The b+b ERP link provides an interface to the customer's ERP system.bb-trace.com · read 10 Oct 2026
- EUDAMED integration
- The b+b repository link provides an interface to Level 5 (EUDAMED).bb-trace.com · read 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.bb-trace.com · read 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.bb-trace.com · read 10 Oct 2026
- Integrations
- The listed modules include an ERP interface and a repository interface to Level 5 (EUDAMED).bb-trace.com · read 9 Oct 2026
- Intended customers
- The maker says its tailored solution serves contract manufacturers and brand owners.bb-trace.com · read 10 Oct 2026
- Line control
- The b+b line manager is a Level 2 component for parameterizing and controlling line components.bb-trace.com · read 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.bb-trace.com · read 9 Oct 2026
- Purpose
- The software supports serialization in medical technology for implementing MDR requirements at Level 3.bb-trace.com · read 10 Oct 2026
- Reporting
- The software can report to multiple markets, customers, or databases.bb-trace.com · read 10 Oct 2026
- Serial number management
- Serial number management is listed as optional.bb-trace.com · read 9 Oct 2026
- Support
- The company lists a service phone number and a support request option on its software modules page.bb-trace.com · read 10 Oct 2026
- Traceability features
- The site manager includes aggregation hierarchy management, serial number management, reworking, and sampling.bb-trace.com · read 10 Oct 2026
- Traceability reporting
- The software supports reporting to multiple markets, customers, and databases.bb-trace.com · read 9 Oct 2026
