Quality Documents
ORIGIO has obtained CE markings for a range of its products. The CE mark covers most of our ORIGIO products, including MediCult Media,
Humagen Pipets, and the MidAtlantic Devices Stripper®, and Cryopette®, among others.
The CE mark ensures that the products comply with the relevant European health and safety legislation. IVF products are covered by the
Medical Device legislation and therefore ORIGIO’s products do comply with the Essential Safety Requirements in the European Medical
Device Directive (93/42/EEC).
- ORIGIO MediCult Media:
*Full quality assurance system: DGM-555
*EC Design examination certificate (includes most of our media): DGM-633
*EC Design examination certificate (new vitrification media): DGM-723
*EC Design examination certificate (EmbryoGen®): DGM-761
- ORIGIO Humagen Pipets & MidAtlantic Devices
- Cryopette®
- ORIGIO B.V. (needles & catheters range)
-SAGE:
*Full quality assurance
*Design Examination
- ORIGIO MediCult Media (ISO 9001/13485)
- ORIGIO Inc (ORIGIO Humagen Pipets & ORIGIO MidAtlantic Devices) (ISO 13485)
- ORIGIO ScanLab Equipment (ISO 9001:2008) awaiting the official certificate
-
SAGE (ISO 13485:2003)