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Understanding UDI requirements - Class 2 medical device (hearing aids)

S

SGquality

Quite Involved in Discussions
#1
#1
We are designing a Class 2 medical device (hearing aids). Need help on understanding the below questions as it relates to Unique Device Identifier (UDI):

1. Does the actual device bear a UDI label or be etched with the DI aspect of UDI and PI being overprinted? If yes, 1D or 2D and if human and machine readable or both?
2. Is UDI label required for immediate box (primary) and carton (secondary) carton also?

Thank you!
 
QMS for Medical Device Companies
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R

RL-WANG

Registered
#4
#4
Hi guys! I found a complete guideline for Unique Device Identification system (UDI system) Application Guide from IMDRF group.
Go to IMDRF webpage www imdrf org and look for IMDRF Documents.
 
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