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Accurx Scribe: Is it a medical device?

Accurx Scribe is powered by Tandem's ambient voice technology, which is registered as a Class I and Class IIa medical device

Written by Sameera
Updated this week

Is Accurx Scribe a medical device?

Accurx Scribe is powered by Tandem’s ambient voice technology, which is registered with the MHRA as a Class I and IIa medical device.

Medical Device Registration details:

GMDN Code - 36216 Digital dictation system

Risk Classification - Class I

Manufacturer - TANDEM HEALTH GLOBAL LIMITED

Medical Device Registration details:

GMDN Code - 61087 Clinical Management Support Software

Risk Classification - Class IIa

Manufacturer - TANDEM HEALTH GLOBAL LIMITED



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