EUDAMED device
OptiFlow II Flowable Composite
EUDAMED device 00818746024743 · The Belport Company, Inc. DBA Gingi-Pak
Key facts
| Primary DI | 00818746024743 |
|---|---|
| Trade name | OptiFlow II Flowable Composite |
| Device name | OptiFlow II Flowable Composite |
| Reference or catalog number | 48221 |
| Manufacturer | The Belport Company, Inc. DBA Gingi-Pak |
| Manufacturer SRN | US-MF-000044279 |
| Risk class | Class IIa |
| EMDN code | Q01010103 |
| EMDN description | DENTAL CONSERVATION COMPOSITES |
| Legislation | mdr |
| Implantable | Yes |
| Sterile | No |
| Single use | Yes |
| Status date | Sep 11, 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: