Dream
Ref DREAM
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 | Number628774088001JC 00628774088002 | Date14 Apr 2025 | 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- Withdrawn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
- Model / Reference
- DREAM
- Primary DI / UDI-DI
- 00628774088002
- Basic UDI-DI
- 628774088001JC
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class I
- Special Device Type
- Software
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CA-MF-000047146
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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