← Back to catalogue
ExactechGPS Total Ankle Case Manager Application
EUDAMEDClass IIa (EU MDR)
Ref L00481
Identity
- Trade Name
- ExactechGPS Total Ankle Case Manager Application EUDAMED
- Device Name
- ExactechGPS Total Ankle Case Manager Application EUDAMED
- Model / Reference
- L00481 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10885862623645 EUDAMED
- Basic UDI-DI
- 10885862100218P5 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ExactechGPS Total Ankle Case Manager Application 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 | 10885862100218P5 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-MF-000002436
Sources (1)
- EUDAMED 201f37f8-d3c5-4f75-897d-b8db8c0a41a2 61 fields · synced Jul 19, 2026