EUDAMED device
Tissue-Tek Genie®
EUDAMED device 00615233010674 · Sakura Finetek USA, Inc
Key facts
| Primary DI | 00615233010674 |
|---|---|
| Trade name | Tissue-Tek Genie® |
| Device name | Tissue-Tek Genie® anti-Ki67 Mouse Monoclonal Antibody [GM027] |
| Reference or catalog number | 8276-C010 |
| Model | Tissue-Tek Genie® anti-Ki67 Mouse Monoclonal Antibody [GM027] |
| Manufacturer | Sakura Finetek USA, Inc |
| Manufacturer SRN | US-MF-000022208 |
| Risk class | Class C |
| EMDN code | W0102039099 |
| EMDN description | TUMOUR MARKERS - OTHER |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Sep 11, 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: