Identity
- Trade Name
- GPS Station v2 User Kit EUDAMED
- Device Name
- GPS Station v2 User Kit EUDAMED
- Model / Reference
- A10012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770041302063 EUDAMED
- Basic UDI-DI
- 3770041302GPSV2USERKIT5G EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The GPS Station v2 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 v2 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 | 3770041302GPSV2USERKIT5G | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-PR-000036416
Sources (1)
- EUDAMED 08c26008-b728-415b-8ade-63197614d65e 61 fields · synced Jun 19, 2026