Brivo XR575
by GE HUALUN MEDICAL SYSTEMS CO. Ltd
Ref 5424711PCMModel Brivo XR575
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00195278448736 00195278448736 | Date1 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- Brivo XR575, 5424711PCM
- Primary DI / UDI-DI
- 00195278448736
- Basic UDI-DI
- B-00195278448736
- EMDN Code
- Z11031101 Multifunctional systems for direct digital radiology
- Device Class
- Class IIb
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001189
- Authorised representative
- GE Medical Systems SCS FR-AR-000000344
Other devices from GE Hualun Medical Systems Co., Ltd
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No