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View Full Version : Class 2a Medical Device (Nebulizer) - What is best route to getting CE mark? Norman Bass 6th July 2008, 08:21 AM Mycompany is the only manufactor of Nebulizer in US. IT is a class 2a -what is best route to geting CE mark? Directives EU LAB Authoried Rep. :bigwave:Norman Bass harry 6th July 2008, 08:28 AM Welcome Norman, Although it is a long weekend, I expect your question to be answered soon. Meanwhile, have a look at this forum: CE Marking (Conformité Européene) / CB Scheme (http://elsmar.com/Forums/forumdisplay.php?f=137) harry 7th July 2008, 07:11 AM This is a bump. Any help is appreciated. somashekar 7th July 2008, 08:36 AM This is a bump. Any help is appreciated. See page 101 and 102 in "Annex 8" of the new approach attached here for proper guidance. Hope this meets Good luck... |
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