Garion+
by SG Healthcare Co., Ltd South Korea EUDAMED
Ref GARION+Model GARION
EMDN Z11039009
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880936528MCASB | Date11 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-MDR/QS-026 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 8 May 2026
- Expires
- 8 May 2031
Specification
- Device Name
- Mobile C-arm X-ray System
- Model / Reference
- GARION, GARION+
- Primary DI / UDI-DI
- 08809365283040
- Basic UDI-DI
- 880936528MCASB
- Direct Marketing DI
- 08809365283040
- EMDN Code
- Z11039009 Fluoroscopy devices
- Device Class
- Class IIb
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- KR-MF-000011322
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Sg Healthcare Co, Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 9d7c43f3-038a-47ad-8e97-5bb4c368a176