EUDAMED device

MEDRAD® Spectris Solaris Sterile Disposables System Syringe Kit

EUDAMED device 00616258024998 · Bayer Medical Care Inc.

Key facts

Primary DI 00616258024998
Trade name MEDRAD® Spectris Solaris Sterile Disposables System Syringe Kit
Device name MEDRAD® Spectris Solaris Sterile Disposables System Syringe Kit
Reference or catalog number FFA 50
Manufacturer Bayer Medical Care Inc.
Manufacturer SRN US-MF-000007050
Risk class Class IIa
EMDN code A03020101
EMDN description LOW PRESSURE EXTENSION LINES
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
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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