Decision Diagnostics Corp (DECN)

[IPwatcher]

I hate to admit it but without any verifiable proof it is just rumor.

Correct. If even that!

I want to believe that this distributor has the CE designation on their site as an indication of CE approval and not just a copy/paste error.

My guess? Someone at DECN probably told them it WAS CE marked. They trusted and believed them. And put it on their website without checking. German SME with 3 staff members? Would YOU check!?

Why doesn’t the EU have a searchable database for CE products? I mean they make you apply for approval why not have a public database?

Its because the EU does not ISSUE CE marks. That is the job of the notified bodies.
The EU makes the rules. The EU member state government enforce those rules.

In IVD the CE designation is given out by a Notified body.
These guys allow you to search their certifications - its part of their remit to do so. (They have to! Certifications are public!)

So the CE mark itsellf points you to the notarised body, and the notarised body's website gets you to the certification.
e.g here is the portal for the BSI notified body:
https://www.bsigroup.com/en-GB/our-services/certification/certificate-and-client-directory/

And here is the one for TUV:
https://www.certipedia.com/

If you know which certified body issued the CE you can get to the certification. The Notified body is identified by the 4 digit code on the CE mark.

If we look at the CE mark on the UK issue of Roche's accu chek performa nano test strips you will see that it is listed as "CE 0123"
This "0123" tells us that TUV-SUD is the Roche notified body.
If we go to the TUV website (above), we can search accuchek and find this:
https://www.certipedia.com/companies/271220/product_certificates?locale=en

https://www.certipedia.com/quality_marks/0000060028?locale=en&certificate_number=PL+4601676+008-1

We need that 4 digit code to identify the notified body. Then we can all go to their website and all look up the certification. If its not there? That probably means the certification isn't there either!

No results for Genviro on TUV.
No results for Genviro on BSI.

Here are all the other MDR certified notified bodies. There is not all that many! If Genviro HAS a CE mark, it will be found on one of these notified bodies websites. There's only about 20 or so to check.
https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

Let me know how you get on! (But I suspect I already know!)

Note... its possible to file under a different (non MDR) category.
You can search here to see which notified bodies cover which categories.
You can try and guess which category Genviro may file under. And who they may have used.
Or get a 4 digit code from the box... if the certification actually exists, that is ! ( I doubt it!)
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34