EUDAMED device
Mach-2®
EUDAMED device 00810000524129 · Parkell Inc.
Key facts
| Primary DI | 00810000524129 |
|---|---|
| Trade name | Mach-2® |
| Device name | Cinch, Mousse & Mach Impression Materials |
| Reference or catalog number | S432 |
| Manufacturer | Parkell Inc. |
| Manufacturer SRN | US-MF-000003761 |
| Risk class | Class I |
| EMDN code | Q01020102 |
| EMDN description | DENTAL IMPRESSION VINYLSILOXANS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 17, 2022 |
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: