Holder
by Tsunami Medical SRL 37 variants
Ref BOK-GL-01-03, BOK-LTH-03, BOK-CSZ-03, BOK-LDJ-01, BOK-IDF-01, BOK-LCH-02, BOK-LT-96, BOK-LC-51S, BOK-LO-01-01, BOK-ACA-01S, BOK-CSZ-05, BOK-VNT-27, BOK-LD-02T, BOK-GL-01-01, BOK-J-EX01, BOK-ACOJ-01, BOK-LCH-01, BOK-LD-01T, BOK-VNT-30, BOK-VNT-21, BOK-LD-01B, ZURI1001, BOK-CSZ-06, BOK-LD-01TB, BOK-VNT-02, BOK-AFF-01, BOK-ACAJ-02, BOK-CSZ-02, BOK-VNT-31, BOK-CS-01S, BOK-GL-01
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 | Number8055202HOLDERRP | Date30 Sep 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- Withdrawn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
- Holder
- Model / Reference
- BOK-GL-01-03, BOK-LTH-03, BOK-CSZ-03, BOK-LDJ-01, BOK-IDF-01, BOK-LCH-02, BOK-LT-96, BOK-LC-51S, BOK-LO-01-01, BOK-ACA-01S, BOK-CSZ-05, BOK-VNT-27, BOK-LD-02T, BOK-GL-01-01, BOK-J-EX01, BOK-ACOJ-01, BOK-LCH-01, BOK-LD-01T, BOK-VNT-30, BOK-VNT-21, BOK-LD-01B, ZURI1001, BOK-CSZ-06, BOK-LD-01TB, BOK-VNT-02, BOK-AFF-01, BOK-ACAJ-02, BOK-CSZ-02, BOK-VNT-31, BOK-CS-01S, BOK-GL-01
- Primary DI / UDI-DI
- 08055202036168, 08055202022055, 08055202026886, 08055202027227, 08055202036175, 08055202026978, 08055202028170, 08055202010403, 08055202036243, 08055202036137, 08055202036250, 08055202025148, 08055202027043, 08055202036151, 08055202027166, 08055202036069, 08055202026961, 08055202032917, 08055202025179, 08055202025087, 08055202019024, 08055202036465, 08055202027951, 08055202029405, 08055202024943, 08055202036120, 08055202027159, 08055202026879, 08055202025186, 08055202032924, 08055202036144
- Basic UDI-DI
- 8055202HOLDERRP
- 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