EUDAMED device
TriplePlay
EUDAMED device 00817377021077 · Dymedix Diagnostics, Inc.
Key facts
| Primary DI | 00817377021077 |
|---|---|
| Trade name | TriplePlay |
| Device name | TriplePlan Airflow |
| Reference or catalog number | 12-40205-0001 |
| Model | TriplePlay Airflow Sensors |
| Manufacturer | Dymedix Diagnostics, Inc. |
| Manufacturer SRN | US-MF-000015691 |
| Risk class | Class I |
| EMDN code | Z12100585 |
| EMDN description | POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jun 24, 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: