Identity
- Trade Name
- X-Guide EUDAMEDFDA UDI
- Generic Name
- Surgical planning/navigation-enhancement system FDA UDI
- Device Name
- X-Guide Surgical Navigation System EUDAMEDX-GUIDE (115V) FDA UDI
- Model / Reference
- P011000 EUDAMEDFDA UDI
- Description
- X-GUIDE (115V) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817421021794 EUDAMED00817421021787 FDA UDI
- Basic UDI-DI
- B-00817421021794 EUDAMED
- FDA Product Code
- PLV FDA UDIQRY FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Surgical planning/navigation-enhancement system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
X-Guide by X-Nav Technologies, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817421021794 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 454eeab4-c07d-498c-be50-2a6f27004776 61 fields · synced May 31, 2026
- FDA UDI 7c9cb588-ac9b-49a7-a561-60a410dbb3a6 34 fields · synced May 30, 2026