T1CMR Phantom (3.0T)
by Resonance Health Analysis Services
Ref 000648
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number93555290CMR3D 93555290000648 | Date5 Jan 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- CMR Phantoms
- Model / Reference
- 000648
- Primary DI / UDI-DI
- 93555290000648
- Basic UDI-DI
- 93555290CMR3D
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- AU-MF-000026337
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Resonance Health Analysis Services
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