Jun 25 2012
ETView (TASE: ETVW) today announced that the company has received pre-market clearance for the VivaSight™-DL product family following review of a Technical File submission by Medical Device Certification GmbH ("MDC").
The pre-market clearance completes the Conformité Européenne, or "European Conformity" ("CE"), registration process. Following award of CE registration, the Company expects to immediately begin distribution of the VivaSight™-DL line of innovative airway devices in countries requiring CE registration of medical devices. In May, 2012, VivaSight-DL received US FDA clearance of a 510(k) Pre-Marketing Notification. Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.
Source: ETView