HITM Green
by C-RAD Positioning AB United States EUDAMED
Ref SP006-0021Model HITSD Red
EMDN Z119010
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number735000528HITED | Date11 May 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- HITSD Red
- Model / Reference
- HITSD Red, SP006-0021
- Primary DI / UDI-DI
- 17350005280434
- Basic UDI-DI
- 735000528HITED
- Direct Marketing DI
- 17350005280434
- EMDN Code
- Z119010 Laser systems for patient positioning
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- SE-MF-000022326
Other devices from C-Rad Positioning Ab
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 bb5dbcde-59f2-4846-8b1e-a43e6d9f676f