Cerebro
Ref CER-0011
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 | Number489714105CER0011AZ 48971410500100 | Date14 Apr 2025 | 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- Withdrawn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
- Model / Reference
- CER-0011
- Primary DI / UDI-DI
- 48971410500100
- Basic UDI-DI
- 489714105CER0011AZ
- Direct Marketing DI
- 48971410500100
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- HK-MF-000034432
- Authorised representative
- Obelis s.a. BE-AR-000000106
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