EUDAMED device

Autoplex® ELISA & CLIA Analyzer

EUDAMED device 00816870020075 · Monobind Inc.

Key facts

Primary DI 00816870020075
Trade name Autoplex® ELISA & CLIA Analyzer
Device name AutoPlex ELISA Analyzer - Single Plate
Reference or catalog number IN006
Model IN006
Manufacturer Monobind Inc.
Manufacturer SRN US-MF-000021611
Risk class Class A
EMDN code W0201020101
EMDN description AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Legislation ivdr
Implantable No
Sterile No
Single use No
Status date Jan 17, 2024

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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