Identity
- Trade Name
- TKA Plus EUDAMED
- Device Name
- TKA Plus EUDAMED
- Model / Reference
- L00043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10885862595850 EUDAMED
- Basic UDI-DI
- 10885862100104NM 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
TKA Plus 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 | 10885862100104NM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-MF-000002436
Sources (1)
- EUDAMED 452c2e12-3f55-48b8-806d-0934ea1b8909 61 fields · synced Jul 9, 2026