EUDAMED device
PRIMA ENT
EUDAMED device 00810178550234 · Labo America Inc.
Key facts
| Primary DI | 00810178550234 |
|---|---|
| Trade name | PRIMA ENT |
| Device name | Surgical (Operating) Microscopes |
| Reference or catalog number | 6137000 |
| Model | Prima,Prima Mu,Prima Swift,Stella,Stella N,Prima Lite |
| Manufacturer | Labo America Inc. |
| Manufacturer SRN | US-MF-000044352 |
| Risk class | Class I |
| EMDN code | Z12011101 |
| EMDN description | OPERATIVE MICROSCOPES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | May 28, 2025 |
At a glance
- No 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: