ImageR2 (FerriScan and CardiacT2*)
by Resonance Health Analysis Services
Ref Version 4.0.0
Active
CE MDR
Valid until
21 Aug 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000316512 | Date13 May 2026 | StatusActive |
Certificates
- 1000316512 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 13 May 2026
- Expires
- 21 Aug 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Standalone Software (Software as Medical Devices)
- Model / Reference
- Version 4.0.0
- Primary DI / UDI-DI
- 93555290000020
- Basic UDI-DI
- 93555290SMD4Z
- Direct Marketing DI
- 93555290000020
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- Special Device Type
- Software
- 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