EUDAMED device

Substrate Mix Container Pack

EUDAMED device 00816879028775 · Hycor Biomedical LLC

Key facts

Primary DI 00816879028775
Trade name Substrate Mix Container Pack
Device name NOVEOS® Immunoassay System Accessories
Reference or catalog number FX64006
Manufacturer Hycor Biomedical LLC
Manufacturer SRN US-MF-000031449
Risk class Class A
EMDN code W0201020180
EMDN description AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
Legislation ivdr
Implantable No
Sterile No
Single use Yes
Status date Dec 18, 2023

At a glance

  • No 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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