Identity
- Trade Name
- GPS Station v3 User Kit EUDAMED
- Device Name
- GPS Station v3 User Kit EUDAMED
- Model / Reference
- A10032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770041302032 EUDAMED
- Basic UDI-DI
- 3770041302GPSV3USERKIT63 EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The GPS Station v3 User Kit is indicated to be used with the Blue Ortho navigation system during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
GPS Station v3 User Kit by Blue Ortho SAS — 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 | 3770041302GPSV3USERKIT63 | Class I | Active |
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Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-PR-000036416
Sources (1)
- EUDAMED 30fc6457-b066-48e9-8943-1dcddc096a1e 61 fields · synced Jul 12, 2026