Sentimag Base Unit
Ref R-SMB02
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 | Number506039121SentimagDK 15060391210602 | Date2 Jul 2026 | 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- Withdrawn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
- Device Name
- Sentimag
- Model / Reference
- R-SMB02
- Primary DI / UDI-DI
- 15060391210602
- Basic UDI-DI
- 506039121SentimagDK
- Direct Marketing DI
- 15060391210602
- EMDN Code
- A019012 Breast nodules and other structures localisation needles and systems
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000007233
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Endomagnetics Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: 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