Mobile - Portable X-Ray Unit
by Sedecal, S.A. (Sociedad Española De Electromedicina Y Calidad, S.A.) 38 variants
Ref SMR-32Model PHOENIX, EASY MOVING, MOBIXRAY, PrimeX, SPL, DRAGON X, PEGASUS, CYCLOPS
Active
CE MDR
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/MDR | Number843604600MOBILECM | Date17 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Mobile - Portable X-Ray Unit
- Model / Reference
- PHOENIX, EASY MOVING, MOBIXRAY, PrimeX, SPL, DRAGON X, PEGASUS, CYCLOPS, SMR-32
- Primary DI / UDI-DI
- 08436046000834
- Basic UDI-DI
- 843604600MOBILECM
- EMDN Code
- Z11039016 Mobile radiographic units
- Device Class
- Class IIb
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000017998
Other devices from Sedecal, S.A. (Sociedad Española De Electromedicina Y Calidad, S.A.)
See all devices from Sedecal, S.A. (Sociedad Española De Electromedicina Y Calidad, S.A.) →
Properties
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