Identity
- Device Name
- Stealth AXiS Platforms EUDAMED
- Model / Reference
- 9736484 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00763000914066 EUDAMED
- Basic UDI-DI
- 0763000B00033818C EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Stealth AXiS Platforms by Medtronic Navigation, Inc. — Class I — 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 | 0763000B00033818C | Class I | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation Inc.
- EUDAMED SRN
- US-MF-000023263
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (1)
- EUDAMED d15f1923-e2ec-4d4e-83ad-5c0289551223 61 fields · synced Jun 19, 2026