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medical device UDI requirements

informationalHealthcare & WellnessAnalyzed 07/01/2025

AI Search Visibility Analysis

Analyze how brands appear across multiple AI search platforms for a specific prompt

Prompt Report Analysis Visualization
High Impact

Total Mentions

Total number of times a brand appears

across all AI platforms for this prompt

Reach

Platform Presence

Number of AI platforms where the brand

was mentioned for this prompt

Authority

Linkbacks

Number of times brand website was

linked in AI responses

Reputation

Sentiment

Overall emotional tone when brand is

mentioned (Positive/Neutral/Negative)

Brand Performance Across AI Platforms

3
Platforms Covered
7
Brands Found
31
Total Mentions
BRANDTOTAL MENTIONSPLATFORM PRESENCELINKBACKSSENTIMENTSCORE
1FDA
26
6
95
2GS1
2
1
59
3Greenlight Guru
1
2
58
4HIBCC
1
0
55
5ICCBBA
1
0
55
6Emergo
0
2
55
7Rimsys
0
2
55
Referenced Domains Analysis
All 12 domains referenced across AI platforms for this prompt
ChatGPT
Perplexity
Google AIO
ChatGPT:
0
Perplexity:
2
Google AIO:
1
3
ChatGPT:
3
Perplexity:
0
Google AIO:
0
3
ChatGPT:
0
Perplexity:
1
Google AIO:
1
2
ChatGPT:
0
Perplexity:
1
Google AIO:
1
2
ChatGPT:
0
Perplexity:
1
Google AIO:
1
2
ChatGPT:
0
Perplexity:
1
Google AIO:
0
1
ChatGPT:
0
Perplexity:
1
Google AIO:
0
1
ChatGPT:
0
Perplexity:
0
Google AIO:
1
1
ChatGPT:
0
Perplexity:
0
Google AIO:
1
1
ChatGPT:
0
Perplexity:
0
Google AIO:
1
1
ChatGPT:
0
Perplexity:
1
Google AIO:
0
1
ChatGPT:
1
Perplexity:
0
Google AIO:
0
1

Strategic Insights & Recommendations

Dominant Brand

FDA dominates as the primary regulatory authority mentioned across all platforms for UDI requirements, with extensive coverage of their GUDID database and compliance framework.

Platform Gap

Perplexity provides the most comprehensive coverage including EU MDR requirements and global aspects, while ChatGPT and Google AIO focus primarily on FDA requirements.

Link Opportunity

Strong opportunities exist for linking to FDA official resources, issuing agency websites like GS1, and compliance consulting services mentioned across platforms.

Key Takeaways for This Prompt

UDI requirements mandate unique identifiers on medical device labels and packaging in both human-readable and machine-readable formats.

Compliance deadlines are phased by device classification, with Class III devices having the earliest requirements and Class I devices the latest.

Manufacturers must submit device information to regulatory databases (GUDID for FDA, Eudamed for EU) and work with accredited issuing agencies.

Both FDA and EU MDR have similar UDI structures but different implementation timelines and database requirements for global compliance.

AI Search Engine Responses

Compare how different AI search engines respond to this query

ChatGPT

4168 Characters

BRAND (4)

FDA
GS1
HIBCC
ICCBBA

SUMMARY

The FDA's UDI system requires medical device manufacturers to include unique identifiers on labels and packaging in both plain text and machine-readable formats. The UDI consists of a Device Identifier (DI) and Production Identifier (PI), with compliance deadlines varying by device class. Manufacturers must submit device information to the GUDID database and work with FDA-accredited issuing agencies like GS1, HIBCC, or ICCBBA.

Perplexity

5064 Characters

BRAND (5)

FDA
GS1
Greenlight Guru
Emergo
Rimsys

SUMMARY

Medical device UDI requirements ensure unique identification throughout distribution and use. Key components include Device Identifier (DI) and Production Identifier (PI) in human-readable and AIDC formats. FDA requires GUDID database submission with phased compliance by device class, while EU MDR has similar requirements with Eudamed database submission and different timelines. Both systems enhance traceability and post-market surveillance.

Google AIO

1779 Characters

BRAND (4)

FDA
Greenlight Guru
Emergo
Rimsys

SUMMARY

FDA mandates UDI system for medical devices to enhance patient safety and tracking. Requirements include UDI labeling on devices and packaging, direct marking on reusable devices, GUDID database submission, and presentation in both plain text and AIDC formats. UDI comprises Device Identifier and Production Identifier components, with compliance varying by device classification.

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