Sibelsound 400 A

Sterile

A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.

Single-use device

A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.

Contains latex

A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.

CMR substance

A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.

Endocrine-disrupting substance

An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

Notified body

A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.