EUDAMED device

PrisMatic® ELISA Analyzer

EUDAMED device 00816870020068 · Monobind Inc.

Key facts

Primary DI 00816870020068
Device name PrisMatic® ELISA Analyzer
Reference or catalog number IN013
Model IN013
Manufacturer Monobind Inc.
Manufacturer SRN US-MF-000021611
Risk class Class A
EMDN code W0201020201
EMDN description IMMUNOCHEMISTRY READERS
Legislation ivdr
Implantable No
Sterile No
Single use No
Status date Feb 4, 2025

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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