Iatriki Tomi - Sealtec company was founded in 2003 in order to distribute medical devices. Twenty years of experience motivated us to proceed with not only distributing but manufacturing MDs. The idea of manufacturing was there at first place but we had to overcome all the difficulties to achieve it. A huge one was added, when MDR was applied in the EU market. In 2024 we completed all the technical files according to MDR with Ostomy products. On May, an Ostomy product portfolio of 13 will be launched for the EU market. Soon, more products will be launched to complete the portfolio.
Patient oriended pathway is in our mentality.
As we have collected experience from distributing some of the market standard brands, we combined experience with knowledge, and pasion for quality of the treatment of patients. At the same time, we know exactly how to offer the best quality and price ratio.
We apply the principle of Total Quality Management in all departments, we train all engaged individuals bearing safety and efficiency in mind. We apply all the certifications provided by the industry in order to fulfill all the requirements for the legal and safe disridution of our products in EU. We are excited on what and how we do it.
Iatriki Tomi - Sealtec is an active member of the Association of Medical & Biotechnological Products "SEIV". Also registered on all the Competend Authorities in Greece. Active member on EUDAMED.
As a member of the Association, our company has accepted and adopted:
*The principle of Ethical Professional Practice
*The Compliance Guidelines for the Protection of Free Competition
*The principle of ethics of SEIB
*ISO 13485
*ISO 9001
*ISO 14001
*ISO 27001
*ISO 37001
*ISO 45001
*Recycle Process etc.
Our path
2003
Iatriki Tomi - Sealtec was established in Thessaloniki as a distributor of Medical Devices.2004
Adoption of ISO 9001.2005
Ostomy & Incontinence products distribution2008
Third party manufacturing on OBL role by 93/42/EEC rule, ISO13485 and management of our new Brand "JET" on cardiovascular stents market.2013
Athens Office establishment.2013
Distribution of Ostomy Care products as exclusive Distributor.2018
Adoption of the GDPR Regulation & appointment of a Data Protector Officer (DPO)2020
Athens office moves to new facilities in Ilioupoli.2022
Adoption of a Quality system according to ISO14001, ISO27001, ISO45001.2023
New fully operated facilities in operation, gives the advantage for manufacturing processes in Efkarpia, Thessaloniki.2024
Certification ISO 370012023
Registered as a Manufacturer2024
MDR Compliant Ostomy Care Products2025...
The Best is yet to come...New production line for Medical Devices is coming
