MDR-05-01

Named Class I organizer

منظم مصنف من المستوى الأول

Roadmap — not an offer

Name a Class I. File one non-sterile Class I article. Export training crates. Radiopaque only if a material qualifies.

One non-sterile organizer taken from the year-1 prototypes into an EDA file. Sale starts only after registration.

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: EDA pathway, via a licensed factory
Kind: Device candidate
Limit: Roadmap. Not on the market in this catalogue.

What is in the line