TrelliX Detachment Controller
Ref TDC-1
Active
CE MDD
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/MDD | NumberB-00810041650382 00810041650382 | Date12 Jan 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- TDC-1
- Primary DI / UDI-DI
- 00810041650382
- Basic UDI-DI
- B-00810041650382
- EMDN Code
- Z12109001 Detachable coil equipment for brain aneurysms
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- US-MF-000008157
- Authorised representative
- MedR-AR Services B.V. NL-AR-000000120
Other devices from Shape Memory Medical Inc
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No