ICU Medical Inc. attains the "CE Mark"

Business Wire, Dec 9, 1996

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Dec. 9, 1996--ICU Medical Inc. (NASDAQ/NMS:ICUI), the San Clemente-based maker of safe medical connectors, announced Monday that it recently obtained its certificate for ISO 9001/EN46001 and the EC Certificate, generally called the "CE Mark."

"These are significant steps in our international expansion into most European countries, the world's second-largest market for medical devices. ICU Medical is moving aggressively to establish and expand its presence in this market," stated George Lopez, M.D., president and chief executive officer.

ICU is converting its labeling so that the CLAVE product line exported to Europe will bear the "CE Mark" indicating the new (Community European) certification. The remaining product lines of ICU Medical will follow soon after. The EC Certificate assures that ICU Medical has established and maintains a compliant quality system and its products meet the essential requirements of the Medical Device Directive Annex II.

ICU Medical Inc., based in San Clemente, is a leading developer and manufacturer of safe medical connectors.

CONTACT: ICU Medical Inc., San Clemente

Francis J. O'Brien, 714/366-2183