Where can I find a product's CE Mark Number?

[JB0424]

I am seeking the CE mark number assigned to a particular device.

Is there a database that this information is housed in?

 

[pkost]

Re: Where can I find a product's CE Mark number

The CE number relates to the notified body that the manufacturer uses. There is no public database which relates products to a notified body, the easiest solution is to look at the product. Alternatively look at the manufacturers website - they may have their quality/EC certification on the site which may indicate which notified body they use

If you want to convert the number in to a notified body name then you can use this page: http :// ec.europa. eu/ enterprise/ newapproach/ nando/index.cfm?fuseaction=notifiedbody.main - DEAD LINK REMOVED.

 

[JB0424]

Re: Where can I find a product's CE Mark number

I am reviewing a document my company had prepared prior to my arrival. It cites a product with CE mark XXXXXX (6 digits). I am assuming this is specific to the product, not the notified body since the notified body number is 4 digits. I am trying to determine what this 6 digit identifier is, and how to look up this information.

 

[pkost]

Re: Where can I find a product's CE Mark number

Without more detail, I would have to assume it is an internal code, perhaps a certificate number, or maybe the date the product approval was granted - it could be anything! you should ask someone that knows your businesses systems.

It is not a notified body number as these are 4 digits

 

[JB0424]

Re: Where can I find a product's CE Mark number

I would have thought it was some internal reference number too, except this document identifies multiple competitor products for substantial equivalence, and each of the products have a number like this referenced. This document is for review by our notified body, so I cannot imagine it being something specific to my company.

This is the first time I have run across something like this, and unfortunately the company hired a consultant to generate this document. I am hoping I can get a response from the consultant, but that may or may not happen.

 

[pkost]

Re: Where can I find a product's CE Mark number

could it be a 510k number from the FDA?

try here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

 

[SteveK]

BSI who are NB 0086, do put a certificate number (as alluded to by pkost) as CE followed by five or six numbers. It is just that, the certificate number, not the 4 digit NB number (that should be elsewhere on the document). Different NBs (there are circa 70 for medical devices) just have their different ways!

Steve

 

[JB0424]

I just checked, and it does not return any results in the 510(k) database.

The document actually states "DEVICE has been CE marked (CE XXXXXX) in the EU".

This is a head scratcher for me.

 

[JB0424]

This might be it! I did look up the packaging of the product to determine the notified body. It is not BSI, but that may be it. Thanks!!!

 

[Ronen E]

I just checked, and it does not return any results in the 510(k) database.

The document actually states "DEVICE has been CE marked (CE XXXXXX) in the EU".

This is a head scratcher for me.

If you provided the number(s) we might have been able to investigate further. Possibly in a PM.

Cheers,
Ronen.