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b+b trace UDI Software

bb-trace.com

WindowsSelf-hosted
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Spec score 7.5 #10 of 29 in Product Serialization Software

What it is

b+b trace UDI Software provides serialization for medical devices to support Medical Device Regulation implementation at level 3. Users can create, edit, and import work or process orders, then report traceability information to multiple markets, customers, and databases. Modules cover user and rights management, audit trails, customer and target-market records, items, lines, interfaces, and label layouts. Site management includes aggregation hierarchy management, reworking, sampling, and optional serial-number management. A multipack manager can combine items across GTINs and aggregate them under a new serial number. Interfaces connect with a customer’s ERP system and with Level 5 of EUDAMED. The line manager is described as a Level 2 component for parameterizing and controlling line components. The SiteServer can run on-premise or in the cloud, using a Windows VM and MS SQL Server database supplied by the customer. Pricing is on request. Tailored support contracts are available; SLA customers receive priority support and free software updates while the SLA remains valid.

Spec sheet

Purpose
The software supports serialization in medical technology for implementing MDR requirements at Level 3.Read 10 Oct 2026 · bb-trace.com
Integrations
The listed modules include an ERP interface and a repository interface to Level 5 (EUDAMED).Read 9 Oct 2026 · bb-trace.com
Support
The company lists a service phone number and a support request option on its software modules page.Read 10 Oct 2026 · bb-trace.com
Headquarters
Oberzent, GermanyRead 28 Sep 2026 · bb-trace.com
Founded
2006Read 28 Sep 2026 · bb-trace.com
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.Read 10 Oct 2026 · bb-trace.com
Aggregation
The multipack manager can create cross-GTIN multipacks and aggregate them to a new serial number.Read 9 Oct 2026 · bb-trace.com
Audit trail
The maker describes the audit trail as similar to CFR 21 Part 11.Read 10 Oct 2026 · bb-trace.com
Database access
b+b provides the SQL Server database table structures, and the customer receives read access to table data.Read 10 Oct 2026 · bb-trace.com
ERP integration
The b+b ERP link provides an interface to the customer's ERP system.Read 10 Oct 2026 · bb-trace.com
EUDAMED integration
The b+b repository link provides an interface to Level 5 (EUDAMED).Read 10 Oct 2026 · bb-trace.com
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.Read 9 Oct 2026 · bb-trace.com
Infrastructure
The customer provides a Windows VM and MS SQL Server database; the SiteServer can run on-premise or in the cloud.Read 10 Oct 2026 · bb-trace.com
Intended customers
The maker says its tailored solution serves contract manufacturers and brand owners.Read 10 Oct 2026 · bb-trace.com
Line control
The b+b line manager is a Level 2 component for parameterizing and controlling line components.Read 10 Oct 2026 · bb-trace.com
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.Read 9 Oct 2026 · bb-trace.com
Reporting
The software can report to multiple markets, customers, or databases.Read 10 Oct 2026 · bb-trace.com
Serial number management
Serial number management is listed as optional.Read 9 Oct 2026 · bb-trace.com
Traceability features
The site manager includes aggregation hierarchy management, serial number management, reworking, and sampling.Read 10 Oct 2026 · bb-trace.com
Traceability reporting
The software supports reporting to multiple markets, customers, and databases.Read 9 Oct 2026 · bb-trace.com
User controls
Available modules include user and rights management, with an audit trail in all modules.Read 10 Oct 2026 · bb-trace.com
Work orders
Users can create, edit, and import work orders or process orders.Read 10 Oct 2026 · bb-trace.com

Strong points and limits

Strong points

  • Supports work-order creation, editing, and importing
  • Traceability reporting across markets and databases
  • ERP and EUDAMED interfaces listed
  • Aggregation and cross-GTIN multipacks supported
  • Audit trails available in all modules

Limits

  • Pricing is available only on request
  • Customer must provide Windows VM and MS SQL Server
  • Serial-number management is optional
  • Requires self-hosted infrastructure or cloud SiteServer setup

Who it suits

The software is positioned for medical-device contract manufacturers and brand owners managing serialization, aggregation, regulatory reporting, and production-line data.

Verdict

b+b trace UDI Software covers serialization, traceability, aggregation, interfaces, and line control for regulated medical-device operations. Buyers need to account for supplied infrastructure and request pricing directly.

Where Specifiction places it

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