CE Mark Requirements for Dentist Chair

[JAMIL]

can anyone give me details regarding ce mark for dentist chair


regards


jamil vora

[Paul Simpson]

Originally Posted by JAMIL

can anyone give me details regarding ce mark for dentist chair


regards


jamil vora

Hi, Jamil and welcome to the cove.

In order to answer your question you need to provide some more information:

• What EU Directives are you interested in? E.g. Machinery Directive, Low Voltage Directive
• What is your company's role in the supply chain? Are you designing, manufacturing, distributing

[somashekar]

Originally Posted by JAMIL

can anyone give me details regarding ce mark for dentist chair


regards


jamil vora

I guess you have a need to get a CE mark for your product which is a dentist chair and you term it as a medical device. Have you gone through the medical device classification per the MDD and do you know its class. Are you from a ISO 13485 certified company ? You need to give out much more details in order to get correct directions. Its pretty straight forward and can be done by notified bodies who have established well in India.
Hope you will be able to share details for direction. good luck...

[yesyoucan]

Originally Posted by JAMIL

can anyone give me details regarding ce mark for dentist chair


regards


jamil vora

try to look for
"Computer Controlled Integral Dental Unit TOP 308"

[SilverHawk]

Dentist Chair is Class I product. Get your company certified to ISO 13485 and apply Annex VII with Declaration of Comformity for CE Mark. Since it is a Class I product, intervention of a Notified Body is not necessary an dthere will be no Notified Body number to be appeared with the CE mark.

[maxenix]

Originally Posted by SilverHawk

Dentist Chair is Class I product. Get your company certified to ISO 13485 and apply Annex VII with Declaration of Comformity for CE Mark. Since it is a Class I product, intervention of a Notified Body is not necessary an dthere will be no Notified Body number to be appeared with the CE mark.

I agree!