MDR-01-05

Positioning jig and organizer prototypes

نماذج مثبت ومنظم

Offered in year 1

Open the door. Invoice services and non-device models. No EDA device file yet.

Holders and tray organizers for lines and tools that are used every day and imported today. Prototypes only in year 1.

A custom splint is drawn on the scan before anything is printed. A jig follows the same order: design on the anatomy, then make the part. This clip is a public design example. It is not a MEDRA device and it is not for sale.

Regulatory posture: Intended Class I, non-sterile. Not filed and not for sale as a device until EDA registration and a factory licence exist.
Who it is for: Cath lab and theatre
Kind: Aid
Limit: Not sterile. Not registered. Not for sale outside the hospital.

What is in the line