ZipThaw is FDA cleared, CE Mark, and more

People often ask if ZipThaw is FDA approved. Medical devices are “cleared” while pharmaceuticals are “approved” by the FDA. ZipThaw is FDA 510k cleared as a class 2 medical device. ZipThaw also has CE Mark and MDR compliance, which means it can be used in the European Union (EU).  ZipThaw also has received ISO 13485 and UL authorization, among other compliance standards, which is a way of determining safety for electronic devices.

Lastly, ZipThaw is rated as AABB Standards-Compliant, which is the premier blood banking industry association and offers additional product compliance standards. This program was called SCOPE and has been renamed. More on AABB standards here.

Not all plasma thawing devices — almost all of which are water baths — have FDA clearance. ZipThaw has FDA clearance as well as a long list of other standards compliances. ZipThaw is an effective, fast, dry, portable and nearly maintenance free medical device for rapid plasma thawing. There is no water to clean with toxic chemicals. It has a handle, simply pick it up to move it. For a quote, email