We are pleased to announce, we have recently been certified to the ISO 13485:2016 standard, an internationally recognized quality system standard, signifying the Quality System at Medifactia AB, which ensures processes are in place to address quality system aspects related to medical devices. This ISO 13485:2016 upgrade shows Medifactia´s commitment to providing agreed levels of […]
In connection with the next Medifactia Transit-Pellets batch, the Transit-Pellets packages will be labeled with an updated carton label.
Effective September 1st, Medifactia’s corporate address has been changed as follows: Medifactia AB c/o IOFFICE BUSINESS CENTER Kungsgatan 60 111 22 Stockholm SWEDEN Other contact information such as phone number(s) and email address(es) remain the same.
In connection with the next Medifactia Transit-Pellets batch, the Transit-Pellets packages will be labeled with an updated carton label. The only difference between the current and updated label is Rx Only and the UDI (GTIN) number. In addition, we have updated the IFU (package insert). Please note that the content has not been changed but […]
UDI/article number 0 7350099 55001 0 inserted. The revised EC Certificate is available under DOCUMENTS.
The EU Medical Device Regulation (MDR), originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021 due to the impact of Covid-19. Manufacturer have had the option of re-certifying MDD certifications to buy some time for compliance with the EU MDR. With that said, there has been certification processes […]
Transit-Pellets radiopaque markers FDA 510(k) Class II clearance for the US-market!
We are pleased to announce the relocation of our office effective date September 1st, 2018. Please update your records with our new contact information: Postal address: Medifactia AB, Lumaparksvägen 7, SE 120 31 Stockholm Visiting address: Ljusslingan 4, 8th floor, SE 120 31 Stockholm Our new phone number effective date September 1st, 2018: +46 (0) […]
We would like to call your attention to the fact that each capsule in a box of Transit-Pellets™ is Vegetable base, with no use or traces of animal products, i.e gelatin capsules, which we use to state in our old Transit-Pellets™ Information Material. This has now been corrected and we would like to advise you […]
Where: Gothenburg, Sweden When: 2017.05.17-2017.05.19 Website: http://gastrodagarna.svenskgastroenterologi.se Stop by Medifactia’s booth during the three day congress for exposure to our full offerings: Transit-Pellets™ and Transit-Pellets™ Monitoring System. Learn more about Transit-Pelletsmethod™ (formerly known as ‘Abrahamsson Method’) from the founder himself, Professor Hasse Abrahamsson. Professor Hasse Abrahamsson COLONIC TRANSIT TIME. Measurement of transit time in clinical […]