Identity
- Trade Name
- GPS Station v3 - Main Unit EUDAMED
- Device Name
- Advita GPS EUDAMED
- Model / Reference
- I00030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770041302001 EUDAMED
- Basic UDI-DI
- 3770041302ADVITAGPS2G EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Neurological stereotactic surgery system
GPS Station v3 - Main Unit by Blue Ortho SAS — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 3770041302ADVITAGPS2G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-MF-000002436
Sources (1)
- EUDAMED 1dfcc348-59f1-4977-a5ca-0b609d2c6ce2 61 fields · synced Jun 17, 2026