Identity
- Trade Name
- GPS Ankle - Case Manager EUDAMED
- Device Name
- GPS Ankle EUDAMED
- Model / Reference
- L00481 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770041302179 EUDAMED
- Basic UDI-DI
- 3770041302GPSANKLENA EUDAMED
- EMDN Code
- Z12011482 SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
GPS Ankle - Case Manager by Blue Ortho SAS — Class IIa — 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 | 3770041302GPSANKLENA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-MF-000002436
Sources (1)
- EUDAMED fb0b2c8f-8119-4dee-8858-f844b0ad867d 61 fields · synced Jun 20, 2026