This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

CorMedix Submits Design Dossier For Neutrolin® (CRMD003) To Start European Approval Process

CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it submitted its design dossier to a prominent European notified body as part of the CE Marking approval process for Neutrolin in the prevention of Catheter Related Bloodstream Infections (“CRBI”) and maintenance of catheter patency in hemodialysis catheters.

The receipt of CE Marking approval will enable the company to market and sell Neutrolin in countries that accept CE Marking which include the 27 countries of the European Union.

CorMedix’s design dossier submission is a compilation of technical documents required as part of the CE Marking approval process. The design dossier will undergo review and audit by the European notified body. A Quality Management System (“QMS”) is currently being implemented by CorMedix and this will subsequently be audited by the notified body. A notified body is a European Union (“EU”) accredited third party authorized to conduct reviews and audits of medical device companies and their devices. Once the design dossier and QMS have been audited and approved by the notified body, a CE certificate will be issued. Further to the CE certificate issuance, a declaration of conformity, which is a legally binding document, must be prepared by the manufacturer stating that the device is in compliance with the applicable Medical Devices Directive in order to affix the CE Marking to the product.

“We are very pleased to have submitted the necessary documents to the notified body in order to continue to advance our CE Marking approval process for Neutrolin. Upon the successful audit and approval of the design dossier and the implementation and successful audit of the QMS, we would anticipate being in a position to obtain CE Marking approval in the first half of 2012,” stated President and Chief Executive Officer, John Houghton.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $95.18 1.64%
FB $117.43 -0.96%
GOOG $692.36 -0.84%
TSLA $232.32 -3.92%
YHOO $36.01 -1.42%


Chart of I:DJI
DOW 17,750.91 -140.25 -0.78%
S&P 500 2,063.37 -18.06 -0.87%
NASDAQ 4,763.2240 -54.37 -1.13%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs