FDA CLASS 2 MEDICAL
DEVICE REGISTRATION CERTIFICATION
My Safe Pass has achieved FDA Class 2 Registration. See below for Qualifications for sale in USA-All
European CE Markets. Exempt Status in most foreign markets reliant on FDA Class II medical Device achievement.
EXAMPLES OF CLASS II MEDICAL DEVICES:
-
Catheters.
-
Blood Pressure Cuffs.
-
Pregnancy Test Kits.
-
Syringes.
-
Blood Transfusion Kits.
-
Contact Lenses.
-
Surgical Gloves.
-
Absorbable Sutures.
CE EURO MARKET
APPROVAL
The Conformitè Europëenne (CE)
CE Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.
