ContiMed Earns CE Mark Certification

ContiMed, Inc., a developer of urologic catheters, announced it has received CE Mark Certification. The certification signifies that the company's products conform with the European Community Medical Device Directive requirements. The company also has received ISO 9001/EN46001 Certification of its quality system for the design, development, production, installation and servicing of its products.

ContiMed began distributing its products internationally in March 1998. The company currently markets its proprietary ContiCath catheter system through independent distributors in Argentina, Brazil, Denmark, Finland, France, Germany, Italy, Norway and Sweden. ContiMed has clinical trials under way in the United States and expects to file a 510 (k) application with the U.S. Food and Drug Administration (FDA) in late 1998 to obtain U.S. market clearance.