Product registration and commercial availability vary. For a complete list, access the link below.
"Approved" - The registration of the product has been approved by the appropriate authority in a given country.
"Cleared" - FDA has agreed that the product is substantially equivalent to a device already legally marketed in the US (per section 510(k)); therefore the product is available for promotion and sale in the US This applies to the US only.
"Marketable" - Product can be promoted and is available for sale; specific to countries where no formal regulatory approval process exists for given product.
Ask your local Grifols representative or contact us for more information on products approved for use in your country.