Identity
- Trade Name
- XL Instrument Set (no disposables) EUDAMED
- Device Name
- Surgical Instrument Sets EUDAMED
- Model / Reference
- 400478 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810055524587 EUDAMED
- Basic UDI-DI
- 081005552iFuseInstSetML EUDAMED
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Surgical instrument sets for placing or removing SI-BONE implants EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
XL Instrument Set (no disposables) by Si-Bone Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005552iFuseInstSetML | Class I | Active |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-PR-000044785
Sources (1)
- EUDAMED c3215142-e20d-440e-8637-193904a94ec7 61 fields · synced Jun 20, 2026