
ONKOCET Ltd. has exhibited the devices from its portfolio on the MEDTEC UK exhibition in Birmingham, April 2011 through our partner Medical & Partners.

The ONKOCET company has successfully reached the certification of yet another medical device, Infrared Camera SVIT. The Certificate can be found here. The videos from the device operation can be found here.
Our device, the non-invasive blood analyzer AMP has won the Golden Incheba prize at a medical exhibition SLOVMEDICA - NON-HANDICAP 2010. A big thank you goes to the organizers of the exhibition for acknowledging the quality of our device and to the exhibitor, the Medical & Partners company, for introduction of the AMP device to the medical public again.
You can find the certificate here.
Our company has finished the certification process for another medical device, computerized spirometer MAS-1K with oximeter. You can find the device certificate here.
Since May 2010 there is a new version of AMP device available.
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In the beginning of 2013 on the site of ResearchGate https://www.researchgate.net/ Phil Petursson raised a question: How do you know that medical devices are reliable, accurate, and safe?
Petursson wrote: “I believe that approval ratings that include: 'CE', 'UL', and 'GS' are only electrical safety ratings, and do not evaluate the reliability and validity (accuracy) of a medical device.“
Is it true that the CE mark on medical devices (MD) means only electrical safety ratings?
Before any producer of medical device labels his product with the CE mark and introduces them on EU market with medical devices, the device must fulfill the conditions written in Directive 93/42/EEC (MDD), 98/79/EC (IVDD) or 90/385/EEC (AIMDD). In practice this process is called „CE registration“.
What does the process of CE registration mean?
The process of CE registration is divided into two parts. First, each producer or EU representant of a manufacturer is obliged to prepare a so called Technical Construction File (TCF).
PDF File: Reliability of medical devices.pdf
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