Unique Device Identification (UDI) Update

Are you selling medical devices in the US and do you need help with compliance to the regulation?

FDA Logo 200xAs of 1st Feb 2016 labellers of Class II medical devices can submit a request to get a GUDID account – click here for more details from the US FDA.

To date over 500,000 devices have been registered to the FDA Global UDI Database (GUDID) and 90% of those devices have a GS1 Unique Identifier/Device Identifier (DI)

Agency

Number of Primary Device   Identifiers for Devices

%

GS1

455,202

90%

HIBCC

49,189

10%

Total

504,391

 

 

If you need to comply with this regulation talk to GS1 Ireland about our trainings and advisory services to support you achieving regulatory compliance.