EUDAMED device
Fortel® Prostate (PSA) Screening Test
EUDAMED device 00083059108118 · Biomerica, Inc.
Key facts
| Primary DI | 00083059108118 |
|---|---|
| Trade name | Fortel® Prostate (PSA) Screening Test |
| Device name | Fortel Prostate (PSA) Screening Test |
| Reference or catalog number | 1081-1 |
| Model | 1081-1 |
| Manufacturer | Biomerica, Inc. |
| Manufacturer SRN | US-MF-000015772 |
| Risk class | IVD Annex II List B |
| EMDN code | W0102160202 |
| EMDN description | PSA - RT & POC |
| Legislation | ivdd |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Sep 24, 2024 |
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: