Identity
- Trade Name
- SurgiCase Knee Planner EUDAMED
- Device Name
- SurgiCase Knee Planner EUDAMED
- Model / Reference
- SurgiCase Knee Planner EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404028001257 EUDAMED
- Basic UDI-DI
- 54040280B1022VG EUDAMED
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
SurgiCase Knee Planner by Materialise NV — 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 | 54040280B1022VG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Materialise NV
- EUDAMED SRN
- BE-MF-000000034
Sources (1)
- EUDAMED 8b3cd53a-a9b1-4c12-a0f7-8c667d5d619c 61 fields · synced Jun 18, 2026