Handle
by Tsunami Medical SRL 8 variants
Ref BOK-LT-73L, BOK-LTH-04, BOK-LT-77, TRQ-02, BOK-GL-01-02, BOK-LC-52, BOK-LT-90-02, BOK-LT-75, BOK-LD-09, ZURI1005
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 | Number8055202HANDLESN4 | Date3 Oct 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- Withdrawn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
- Device Name
- Handle
- Model / Reference
- BOK-LT-73L, BOK-LTH-04, BOK-LT-77, TRQ-02, BOK-GL-01-02, BOK-LC-52, BOK-LT-90-02, BOK-LT-75, BOK-LD-09, ZURI1005
- Primary DI / UDI-DI
- 08055202010410, 08055202022062, 08055202022024, 08055202028163, 08055202028132, 08055202009315, 08055202009117, 08055202022000, 08055202028125, 08055202036489
- Basic UDI-DI
- 8055202HANDLESN4
- EMDN Code
- L1199 Neurosurgery instruments, reusable - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000007198
Other devices from Tsunami Medical SRL
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