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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: BuzzVA who wrote (4626)	9/16/1998 11:40:00 AM
From: JanyBlueEyes	Read Replies (1) \| Respond to 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.

To: BuzzVA who wrote (4626)	9/16/1998 11:56:00 AM
From: Jeffrey L. Henken	Read Replies (1) \| Respond to of 5736

The first step was FDA approval. That was of course achieved well over a year ago. If it was CCSI's intention to manufacture and distribute the device in the USA and then in Europe we would have heard something along those lines by now. Of course those who are short on the stock will tell you there is not enough cash to do any such thing and they would be right. In my opinion CCSI is still pursuing manufacturing and distribution deals for this product here and abroad. In the US we need an ISO 9000 certified product to manufacture the device. In Europe we need the device itself to receive CE Mark. What will CE Mark do for the product? The CE Mark certification allows the company, and it's partner when one is named, to market the device within the 15 countries that comprise the European Economic Community (EEC). Under the European Union Medical Devices Directive, all devices sold onto the market since June 14 (ie. not already in the distribution chain) must bear the CE Mark. So the next logical step is to announce a manufacturing partner. If you are long you hope this will happen soon. InvestRight Regards, Jeff