Device Identification

The Device Identification app provides a platform to create and manage unique identifiers for medical devices. A device identifier (DI) is created for each medical device based on regulations defined by the regulatory authorities under the Unique Device Identification (UDI) system.

This app lets you manage additional information such as secondary DI, package DI, pre-market, clinically relevant size, and storage and handling information. It also helps you to submit DI information to the regulatory authorities through the Electronic Submissions Gateway (ESG).

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What's New
The Device Identification app lets you:
  • Organize and manage unique device identifiers for medical devices.
  • Add additional identifiers such as secondary DI, package DI, premarket, clinically relevant size, and storage and handling information based on the requirement.
  • Generate submission file with DI information according to Health Level 7 (HL7) Structured Product Labeling (SPL) standard.
  • Submit file to the regulatory authority.
  • Store acknowledgments received from the regulatory authority.