Medical devices
search
news
We have exhibited our devices on the prestigious MEDTEC UK exhibition in Birmingham
ONKOCET Ltd. has exhibited the devices from its portfolio on the MEDTEC UK exhibition in Birmingham, April 2011 through our partner Medical & Partners.
12.4.2011 12:27
Certification of SVIT infrared camera completed 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.
4.3.2011 11:38
Certification of Concor Soft Contact Lenses successfully finished. We are pleased to inform our business partners, that our company has succesfully finished the certification process of Concor Soft Contact Lenses.
You can find the certificate
here.
More information on Concor Soft Contact Lenses go to section Medical preparations/Concor soft contact lenses, or follow
this link.
16.6.2010 11:51
Certification of MAS-1K Spirometer successfully finished. Our company has finished the certification process for another medical device, computerized spirometer MAS-1K with oximeter. You can find the device certificate
here.
2.6.2010 10:58
Certification of PLASON device finished, CE issued. Dear partners,
In October 2009 we have received
CE certificate for another device from our portfolio, NO therapeutical device PLASON. You can find more information about this revolutionary device, used for healing of unhealing wounds, diabetic foot, or for cosmetical purposes, at our webpage, section "Medical devices" -> PLASON-NO Therapy.
Best regards
Team of ONKOCET Ltd. company
23.1.2009 15:30
Report on Medical Testing
Report on Medical Testing
Clinical Trials ANESA 2013
REPORT ON CLINICAL STUDIES OF THE MEDICAL DEVICE
“Automatic Noninvasive Express Screening Analyzer ANESA”
Kharkiv, 21-05-2013
Materials on clinical study of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) are provided. It is designed to collect data of a patient's clinical blood analysis values (hemoglobin, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), amylase, total protein, total bilirubin, direct bilirubin, ceruloplasmin, hematocrit, creatinine, leucocytes, lymphocyte, urea, monocytes, erythrocyte sedimentation rate (ESR), differential count – band neutrophils) without invasive blood drawing followed by data processing with “USPIH 10” software.
Clinical study of volunteers was carried out by comparative analysis with using certified hematology analyzers and commonly accepted methods of laboratory examinations. Study results were processed by statistical methods.
This study allowed determining that the test medical device ensures the necessary reproducibility with 95% of confidence interval. Parallel control by the standard (common) laboratory methods is recommended.
More information available in:
ANESA Clinical trial 2013.pdf
The producer of ANESA device held several clinical trials in various countries - Ukraine, Russia, Hungary (EU), Belarus, China, etc.
All the clinics and laboratories were assigned by the respective Notified Body.
Some of the trials were done after registration of the device; they must be characterized as post-clinical trials.
CLINICAL TRIALS ANESA.pdfPDF File: 150 KB Biopromin_Medical_Test_Program_En.pdfPDF File: 140 KB
Biopromin_Medical_Test_Report_En.pdfPDF File: 150 KB
Biopromin_Medical_Test_Report_Tables_En.pdfPDF File: 85 KB
Medical Trial Report Moscow Oncological Research Institute En.pdfPDF File: 400 KB
Clinical Evaluation Hungary.pdfPDF File: 2,3 MB