Identity
- Trade Name
- X-Guide System EUDAMED
- Device Name
- X-Guide Surgical Navigation System EUDAMED
- Model / Reference
- P011000 EUDAMEDP007839 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817421023033 EUDAMED
- Basic UDI-DI
- 081742102XGUIDESNSF5 EUDAMED
- Direct Marketing DI
- 00817421023033 EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIa 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
X-Guide System by X-Nav Technologies, LLC — 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 | 081742102XGUIDESNSF5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- X-Nav Technologies, LLC
- EUDAMED SRN
- US-MF-000003234
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 037ea2d8-ccc9-4dff-9e2a-875d1111871b 61 fields · synced May 23, 2026