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b+b trace UDI Software
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. Users can create, edit, and import work or process orders, then report traceability information to multiple markets, customers, and databases. Its modules cover user and rights management, audit trails, customers and target markets, items, lines, interfaces, and label layouts. Site management includes aggregation hierarchy management, reworking, sampling, and optional serial number management. A multipack manager can form cross-GTIN multipacks and aggregate them under a new serial number. Interfaces are available for a customer's ERP system and for Level 5 (EUDAMED); line management is described as a Level 2 component for configuring and controlling line components. The SiteServer can run on-premise or in the cloud, but the customer provides a Windows VM and MS SQL Server database. The maker describes the software as suited to contract manufacturers and brand owners. Pricing is on request; tailored support contracts are available, and SLA customers receive priority support and free software updates while the SLA remains valid.
Who it suits
The software is intended for medical-device contract manufacturers and brand owners that need serialization, traceability reporting, and aggregation. It may suit customers able to provide the specified Windows and SQL Server infrastructure.
What it does well
- Reports traceability information to multiple markets and databases.
- Supports aggregation, reworking, and sampling.
- Provides ERP and EUDAMED interfaces.
- Includes user controls and audit trails across modules.
- Offers on-premise or cloud SiteServer operation.
What to know first
- Customer must provide a Windows VM and MS SQL Server.
- Serial number management is optional.
- Pricing is on request.
Getting started
- Visit the b+b trace UDI Software website.
- Arrange pricing with b+b, since pricing is on request.
- Provide a Windows VM and MS SQL Server database for the SiteServer.
- Choose whether the SiteServer will run on-premise or in the cloud.
- Request a tailored support contract if needed; SLA customers receive priority support and free software updates while the SLA is valid.
Verdict
b+b trace UDI Software combines device serialization with order, line, aggregation, and reporting modules. Prospective customers should confirm infrastructure requirements and request pricing and any support terms they need.
Questions
How much does b+b trace UDI Software cost?
Pricing is on request.
Who is the software intended for?
The maker describes it as suited to contract manufacturers and brand owners.
Where can the SiteServer run?
It can run on-premise or in the cloud. The customer provides a Windows VM and MS SQL Server database.
Does it connect to ERP systems and EUDAMED?
Listed modules include an interface to the customer's ERP system and a repository interface to Level 5 (EUDAMED).
Is serial number management included?
Serial number management is listed as optional.
What support is available?
Customers can request tailored support contracts. SLA customers receive priority support and free software updates while the SLA is valid.
Facts from b+b trace UDI Software's own pages
- Aggregation
- The multipack manager can create cross-GTIN multipacks and aggregate them to a new serial number. · bb-trace.com, 9 Oct 2026
- Audit trail
- The maker describes the audit trail as similar to CFR 21 Part 11. · bb-trace.com, 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, 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, 10 Oct 2026
- ERP integration
- The b+b ERP link provides an interface to the customer's ERP system. · bb-trace.com, 10 Oct 2026
- EUDAMED integration
- The b+b repository link provides an interface to Level 5 (EUDAMED). · bb-trace.com, 10 Oct 2026
- Founded
- 2006 · bb-trace.com, 28 Sept 2026
- Headquarters
- Oberzent, Germany · bb-trace.com, 28 Sept 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, 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, 10 Oct 2026
- Integrations
- The listed modules include an ERP interface and a repository interface to Level 5 (EUDAMED). · bb-trace.com, 9 Oct 2026
- Intended customers
- The maker says its tailored solution serves contract manufacturers and brand owners. · bb-trace.com, 10 Oct 2026
- Line control
- The b+b line manager is a Level 2 component for parameterizing and controlling line components. · bb-trace.com, 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, 9 Oct 2026
- Purpose
- The software supports serialization in medical technology for implementing MDR requirements at Level 3. · bb-trace.com, 10 Oct 2026
- Reporting
- The software can report to multiple markets, customers, or databases. · bb-trace.com, 10 Oct 2026
- Serial number management
- Serial number management is listed as optional. · bb-trace.com, 9 Oct 2026
- Support
- The company lists a service phone number and a support request option on its software modules page. · bb-trace.com, 10 Oct 2026
- Traceability features
- The site manager includes aggregation hierarchy management, serial number management, reworking, and sampling. · bb-trace.com, 10 Oct 2026
- Traceability reporting
- The software supports reporting to multiple markets, customers, and databases. · bb-trace.com, 9 Oct 2026
- User controls
- Available modules include user and rights management, with an audit trail in all modules. · bb-trace.com, 10 Oct 2026
- Work orders
- Users can create, edit, and import work orders or process orders. · bb-trace.com, 10 Oct 2026
Where b+b trace UDI Software stands on Freedom251
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