How do I install the Udi Labeling Generator skill?

Run npx skillmds@latest add a5c-ai/udi-labeling-generator in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

Is Udi Labeling Generator safe to use?

This skill has not completed SkillMD's automated safety review yet. Independent scanners report: SkillSpector: PASS, Skill Scanner: PASS. Capability flags: docs only. SkillMD never runs a skill's scripts for you; review the SKILL.md before installing.

Which AI agents work with Udi Labeling Generator?

This skill is tagged as working with Claude Code, Claude.ai, OpenAI Codex. SKILL.md is an open format, so most agents that read a skills directory can load it too.

Is Udi Labeling Generator free to use?

Yes. Installing skills from SkillMD is free, and the skill stays under its author's original license.

Who published Udi Labeling Generator?

a5c-ai (@a5c-ai) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Udi Labeling Generator by a5c-ai — Agent Skill

Name: Udi Labeling Generator
Rating: 4.2 (5 reviews)
Author: a5c-ai

File contents

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

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

---name: udi-labeling-generatordescription: Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers--- # 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

Frequently asked questions

Udi Labeling Generator