Roccia Tlif
by Silony Medical GmbH 3 variants
Ref XRT-ST01
Roccia Tlif (XRT-ST01) is a Class I device made by Silony Medical GmbH, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 4054896XRT-ST01FW), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4054896XRT-ST01FW 04054896056548 | Date6 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 4054896XRT-ST01FW
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- ROCCIA TLIF Classic
- Model / reference
- XRT-ST01
- Primary DI / UDI-DI
- 04054896056548
- Basic UDI-DI
- 4054896XRT-ST01FW
- EMDN code
- S010499 Sterilisation containers - other
- Device class
- Class I
- System or procedure pack
- System
- EU registration type
- System or procedure pack
- Medical purpose
- Set of surgical instruments
Manufacturer details
- EUDAMED SRN
- DE-PR-000022276
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