The likely classification of an alcohol prep pad is Class I, rule 1.
In the US, they are Class 1 under the product code of KOY.
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Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
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Original Message:
Sent: 21-May-2019 11:21
From: Anonymous Member
Subject: Alcohol Prep Pads
This message was posted by a user wishing to remain anonymous
I am looking for some advice. I have an EU Class I sterile device. I want to package alcohol prep pads with each device for customer convenience. They could obtain their own prep pads as an alternative. Does the alcohol prep pad require a CE mark? What is the likely classification of the prep pad: (I or IIa)? Thanks for your input!