EUDAMED device

MEDRAD® Spectris Solaris EP MR Injection System

EUDAMED device 00616258008165 · Bayer Medical Care Inc.

Key facts

Primary DI 00616258008165
Trade name MEDRAD® Spectris Solaris EP MR Injection System
Device name MEDRAD® Spectris Solaris EP MR Injection System Accessories
Reference or catalog number SSMR START
Manufacturer Bayer Medical Care Inc.
Manufacturer SRN US-MF-000007050
Risk class Class I
EMDN code A030199
EMDN description CONTROLLERS - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Feb 5, 2026

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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