News - European Union CE Mark Certification
CHROMATICS COLOR SCIENCES RECEIVES EUROPEAN UNION CE MARK CERTIFICATION
NEW YORK, April 28 /PRNewswire/ -- Chromatics Color Sciences International, Inc. (Nasdaq: CCSI) announced that it received notice on April 27, 1999 that it was granted permission on April 7, 1999 by the European Union (EU) notified body, TUV Essen, to affix the CE Mark to its Colormate(R) TLc.BiliTest(TM) System product line.
Display of the CE Mark is evidence that the Company's medical products meet EU medical device requirements and is a prerequisite for purposes of commercial distribution within the EU. With this grant of permission, there is no need for specific product type or lot inspections by the notified body.
Among other things, to be granted such permission the Company passed a full quality assurance system audit by the notified body, TUV Essen, including a technical file review confirming the Company's system for the design, development, production, installations and servicing of its medical products meets strict international safety requirements.
Chromatics Chief Executive Officer Darby Macfarlane said, "We are very pleased to have received this key approval. While specifically supporting our efforts to market the Colormate(R) TLc.BiliTest(TM System in Europe, this development further demonstrates to the medical community worldwide the extent of our quality commitment overall."
In March, CCSI announced that its design control process had received the ISO-9001 and EN46001 certifications, signifying that it had met important quality standards. The Company previously announced that its contract manufacturer also has an ISO-9001 and EN46001-certified facility. The Colormate(R) TLc.BiliTest(TM) System is manufactured by the Company's contract manufacturer in accordance with ISO-9001 and EN46001 regulatory standards and the U.S. Food and Drug Administration's (FDA) Quality System Regulation (QSR), which enumerates current good manufacturing practices governing the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices for U.S. distribution.
The Colormate(R) TLc.BiliTest(TM) System (TLc for tender, loving care is the only device with FDA clearance for commercial use, marketed in the U.S. for pain-free, non-invasive monitoring of hyperbilirubinemia for babies of all races and all gestational ages -- even when undergoing phototherapy treatment. A study of the device published in Pediatrics, the publication of the American Academy of Pediatrics, found that Colormate(R) TLc.BiliTest(TM) System results correlate within a clinically useful range to results obtained from current invasive techniques that involve taking blood from infants -- often repeatedly.
Chromatics Color Sciences is in the business of color science....
Certain of the matters discussed in this announcement contain forward-looking ..... |
