Year 3 · Observatory

MDR-03-06

Consumable-substitution trio

ثلاثية بدائل المستهلكات

Roadmap — not an offer

First licence. One jig family licensed. A pulsatile bench you can book. CHD on retainer.

Three aids chosen from the observatory list because they are used often and imported.

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
CSSD and theatre
Kind
Aid
Limit
Prototypes. Registration is a later, separate decision.

What is in the line

  • Three prototypes
  • Import-volume note