EUDAMED device

Local Run Manager DNA Generate FASTQ Dx Module for NextSeq 550Dx

EUDAMED device 00816270020415 · Illumina, Inc.

Key facts

Primary DI 00816270020415
Trade name Local Run Manager DNA Generate FASTQ Dx Module for NextSeq 550Dx
Device name IDPEDx software module and applications
Reference or catalog number 20063024
Manufacturer Illumina, Inc.
Manufacturer SRN US-MF-000013476
Risk class Class A
EMDN code W010699
EMDN description GENETIC TESTS - OTHER
Legislation ivdr
Implantable No
Sterile No
Single use No
Status date Feb 8, 2023

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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