EUDAMED device
NOVEOS® Immunoassay System
EUDAMED device 00816879022995 · Hycor Biomedical LLC
Key facts
| Primary DI | 00816879022995 |
|---|---|
| Trade name | NOVEOS® Immunoassay System |
| Device name | NOVEOS® Immunoassay System |
| Reference or catalog number | 63000 |
| Manufacturer | Hycor Biomedical LLC |
| Manufacturer SRN | US-MF-000031449 |
| Risk class | Class A |
| EMDN code | W0201020102,W0201020192 |
| EMDN description | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE|AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Mar 22, 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)