EUDAMED device
GEMS Soft Harvest System
EUDAMED device 00819127021610 · Tulip Medical Products, Inc.
Key facts
| Primary DI | 00819127021610 |
|---|---|
| Trade name | GEMS Soft Harvest System |
| Device name | GEMS Tulip Injector (Single) |
| Reference or catalog number | DC1SLSPO1415-10 |
| Model | DC1SLINJ1709-01 |
| Manufacturer | Tulip Medical Products, Inc. |
| Manufacturer SRN | US-MF-000049097 |
| Risk class | Class IIa |
| EMDN code | K01020110 |
| EMDN description | MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Oct 13, 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: