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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 22.38-4.8%Nov 14 9:30 AM EST
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To: BuzzVA who wrote (4626)9/16/1998 11:40:00 AM
From: JanyBlueEyes  Read Replies (1) of 5736
 
CE Mark

I have not seen anything to date where the company announced they obtained certification for the CE mark (although I know it is a priority).

From the 10Q filed 8/14/98 sec.gov :

In order for the Company to market its products in Europe and certain other foreign jurisdictions, the Company and its distributors and agents must obtain required regulatory registrations or approvals and otherwise comply with extensive regulations regarding safety, efficacy and quality in those jurisdictions.

Specifically, certain foreign regulatory bodies have adopted various regulations, among other things, governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. These regulations vary from country to country.

After mid-1998, the Company will be prohibited from selling its Colormate(TM) Bilirubin Device in Europe until such time as the Company receives the right to affix the CE mark, which is a symbol of quality and compliance with applicable European medical device directives. ISO 9001/EN 46001 certification is one option for pursuing the CE mark under the CE mark certification process requirements.
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