So what exactly does that CE Mark mean for the SprayShield (TM)??
Sprayable hydrogel technology offers surgeons a valuable tool to help reduce the incidence, severity and extent of post-surgical adhesions.
NORTH HAVEN, Conn.--(BUSINESS WIRE)--
Covidien (NYSE: COV, BSX: COV), a leading global provider of health care products, today announced that its Surgical Devices business unit has introduced the SprayShield(TM) Adhesion Barrier System throughout Europe. The SprayShield Adhesion Barrier System offers surgeons a unique synthetic, sprayable hydrogel that provides a strong barrier between tissue and organ planes that helps reduce the development of post-surgical adhesions. The SprayShield (TM) Adhesion Barrier System, which has received CE-Mark, is indicated for use in both open and laparoscopic abdominopelvic surgical procedures as an adjunct to good surgical technique.
<><> IHRT "CE Mark Education Center"<><>
European countries have many approaches but there is one common factor in the area of healthcare - the need to have CE-marking on in vitro diagnostic (IVD) products. The European Union’s IVD Directive (applied in December 2003) mandates that all IVD devices used in the human, clinical setting must be registered and have a CE-symbol affixed.
CE MARKING - WHATS IN IT FOR YOU
The good news - The most obvious benefit is that the CE Marking on your product will gain you access to the European Economic Area (EEA). If the European product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking is mandatory and therefore crucial to your success.
There will be only one set of laws and regulations to comply with in designing and manufacturing your product for the entire European Union (EU) marketplace. The multiple and conflicting national restrictions on regulated products will be eliminated.
UNITED STATES General Services Administration
CE MARKING -
The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. For a list of countries that require the CE marking, see: CE Marking Countries. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 27 countries with a population of nearly 500 million.Unfortunately, there is no comprehensive list of the products that require a CE marking.
Is CE Required For Our Product? How Can We Get CE?
"Is CE marking required for our product? Which CE requirements our product has to comply with? Which European harmonized standards apply to our products? Which certification procedures apply?"
"Stat decisions, during clinical studies at Endogyn!"
(Endogyn is only a web site in reality, however, Kru claims to be doing surgery, so...)
Posted Saturday, January 10, 2009 @ 07:49 AM Endogyn message board.
Guess which one gets the best results in Doc. Kru's hands?
This happens after a long laparoscopic adhesiolysis with carbon dioxide gas:
Another conclusion: I strongly believe that the adequate covering of the wounded area with "Catsup(CE)" is only possible WITH gasless laparoscopy. I am also very sure that our results will remain the best as long as no other surgeon performs Lift-laparoscopy for adhesion surgery."
OUCH Covidien!!!! INVESTORS BEWARE
Scarring caused by surgical gel spray
Monday, 11 February 2008
Bravo! Way To Go Dr. Koya! Thank-you for caring! "Applause, Applause" for Dr. Koya
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