EUDAMED device
ivWatch Extension Module
EUDAMED device 00814088020122 · ivWatch, LLC
Key facts
| Primary DI | 00814088020122 |
|---|---|
| Trade name | ivWatch Extension Module |
| Device name | ivWatch Extension Module |
| Reference or catalog number | AE-1001003 |
| Model | Model 400 |
| Manufacturer | ivWatch, LLC |
| Manufacturer SRN | US-MF-000001531 |
| Risk class | Class IIa |
| EMDN code | Z12040192 |
| EMDN description | GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 29, 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: