---
name: udi-labeling-generator
description: Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Regulatory Compliance
  skill-id: BME-SK-004
graph:
  domains: [domain:biomedical-engineering]
  skillAreas: [skill-area:data-analysis, skill-area:compliance-automation, skill-area:python-data-pipelines]
  workflows: [workflow:experiment-design, workflow:peer-review-cycle]
  roles: [role:biomedical-engineer, role:compliance-engineer]
---

# UDI Labeling Generator Skill

## Purpose

The UDI Labeling Generator Skill creates compliant Unique Device Identification labels and manages device identifier assignments for FDA GUDID and EU EUDAMED submissions.

## Capabilities

- UDI-DI and UDI-PI generation
- GUDID data submission preparation
- Label content validation
- IFU (Instructions for Use) template generation
- Multi-language labeling support
- Symbol compliance verification (ISO 15223-1)
- Barcode generation (GS1, HIBCC, ICCBBA)
- Label artwork review assistance
- EUDAMED UDI registration support
- Package hierarchy management
- Date format standardization

## Usage Guidelines

### When to Use
- Creating device labeling for regulatory submission
- Registering devices in GUDID or EUDAMED
- Designing label artwork and content
- Validating labeling compliance

### Prerequisites
- Device identification information finalized
- Issuing agency account established
- Package configuration defined
- Regulatory requirements identified

### Best Practices
- Establish UDI strategy early in development
- Validate barcode readability across packaging
- Ensure symbol usage meets ISO 15223-1
- Maintain consistency across label variants

## Process Integration

This skill integrates with the following processes:
- 510(k) Premarket Submission Preparation
- EU MDR Technical Documentation
- Design Control Process Implementation
- Sterile Barrier System Validation

## Dependencies

- FDA GUDID API
- GS1 standards and databases
- EUDAMED system
- ISO 15223-1 symbol library
- Issuing agency interfaces

## Configuration

```yaml
udi-labeling-generator:
  issuing-agencies:
    - GS1
    - HIBCC
    - ICCBBA
  label-types:
    - device-label
    - package-label
    - shipping-label
  barcode-formats:
    - GS1-128
    - DataMatrix
    - QR-Code
  regulatory-regions:
    - FDA
    - EU-MDR
    - Health-Canada
```

## Output Artifacts

- UDI-DI assignments
- UDI-PI format specifications
- GUDID submission files
- Label content templates
- IFU drafts
- Barcode specifications
- Symbol usage guides
- Multi-language label sets

## Quality Criteria

- UDI format complies with issuing agency requirements
- Labels meet FDA 21 CFR 801 requirements
- EU MDR Annex VI requirements satisfied
- Symbols conform to ISO 15223-1
- Barcodes meet readability specifications
- Package hierarchy accurately represented


---
Source attribution: a5c-ai
Original project: https://github.com/a5c-ai/babysitter
License: MIT
License information: https://opensource.org/license/mit
Original upstream instructions; downloaded from Mega AI Hub.

## Upstream license notice

MIT License

Copyright (c) 2026 Gabriel Moreira

Permission is hereby granted, free of charge, to any person obtaining a copy
of this software and associated documentation files (the "Software"), to deal
in the Software without restriction, including without limitation the rights
to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
copies of the Software, and to permit persons to whom the Software is
furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all
copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
SOFTWARE.



# Mega AI Hub resource metadata

Creator / publisher: a5c-ai
Original project: https://github.com/a5c-ai/babysitter
Attribution basis: Upstream repository explicitly recorded in package mirror path

Fields of work: Data & Analytics, Healthcare & Life Sciences, Marketing, Project & Program Management
Roles: Business Intelligence Analyst, Medical Writer, Product Marketer, Project Manager
Specialties: Specialty not specified
Tools: Eudamed System, Fda Gudid Api, Iso 15223 1 Symbol Library, Gs1 Standards And Databases
Country applicability: Canada, United States
Classification basis: Source catalog labels
Instruction SHA-256: 78f3631268289c96b2102fb67e6cafd5d0d38b1888bdf8880b66525a39495c07