EUDAMED device
OEC One ASD
EUDAMED device 00195278685001 · GE HUALUN MEDICAL SYSTEMS CO. Ltd
Key facts
| Primary DI | 00195278685001 |
|---|---|
| Trade name | OEC One ASD |
| Device name | OEC One ASD |
| Reference or catalog number | OEC One ASD |
| Model | OEC One ASD |
| Manufacturer | GE HUALUN MEDICAL SYSTEMS CO. Ltd |
| Manufacturer SRN | CN-MF-000001189 |
| Risk class | Class IIb |
| EMDN code | Z11039017 |
| EMDN description | MOBILE RADIOSCOPIC UNITS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 18, 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: