Percentage of Class I Medical Devices in market - viz Class I, Class II and Class III

Hi all,

Does any one has the percentage of different classes viz Class I, Class II and Class III amongst all devices in the market ?

I am looking for this information for a presentation.

Thanks

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

Hi

I recently had a similar query in a presentation. Based on the FDA Listing database, there are currently just over 105,000 devices listed,

Class 1: 69248 (65.7%)
Class 2: 32345 (30.7%)
Class 3: 1556 (1.5%)
Unknown: 2282 (2.2%)

If anyone has any numbers for the MDD classification in Europe, I'd be interested in seeing them.

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

Thanks Chris1price. Do you have the weblink for the info ?

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

The databases for Device Listings and Establishment Registrations and can be downloaded as text files from: http://www.fda.gov/cdrh/comp/estregls.html#file3

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

Hi Guys,

I appreciate the advice you give through this forum and i find it very informative.

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

I still am confused with the classification of my device, the device falls under invitrodiagnostic , and it is a filtration device to separate epithelial cells from urine for diagnosing cancer. if u could shed light on which class its falls , it would be grateful

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

niksam said:

I still am confused with the classification of my device, the device falls under invitrodiagnostic , and it is a filtration device to separate epithelial cells from urine for diagnosing cancer. if u could shed light on which class its falls , it would be grateful

Click to expand...

You posted this in another forum. Please don't post the same question in multiple forums. If you are not clear about the answer, please continue your discussion in the original thread.

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

chris1price said:

Hi

I recently had a similar query in a presentation. Based on the FDA Listing database, there are currently just over 105,000 devices listed,

Class 1: 69248 (65.7%)
Class 2: 32345 (30.7%)
Class 3: 1556 (1.5%)
Unknown: 2282 (2.2%)

If anyone has any numbers for the MDD classification in Europe, I'd be interested in seeing them.

Click to expand...

Hi Chris1price,

Do you have any updates for these figures ? Also could you manage to get numbers from Europe ?

Re: Percentage of Class I Medical Devices in market - viz Class I, Class II and Class

Sorry, I normally pull the data from the Registrations and Listing databases that can be downloaded from the FDA web-site. However, they are currently not available, and wont be up again until June 2008.

I don't have any EU information either. If anyone can find a source of this information, please pass it on.