Identity
- Trade Name
- X-Guide EUDAMEDFDA UDI
- Generic Name
- Surgical planning/navigation-enhancement system FDA UDI
- Device Name
- X-GUIDE PLANNING SOFTWARE EUDAMEDX-GUIDE PLANNING SOFTWARE - MS WINDOWS FDA UDI
- Model / Reference
- P008296 EUDAMEDFDA UDI
- Description
- X-GUIDE PLANNING SOFTWARE - MS WINDOWS FDA UDI
Identifiers
- Catalog Number
- P008296 FDA UDI
- Primary DI / UDI-DI
- 00817421020001 EUDAMEDFDA UDI
- Basic UDI-DI
- 081742102XGUIDEPLAN4K EUDAMED
- Direct Marketing DI
- 00817421020001 EUDAMED
- 510(k) Number
- K150222 FDA UDI
- FDA Product Code
- PLV FDA UDI
- EMDN Code
- Z12011492 SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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
- Special Device Type
- Software EUDAMED
- 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
X-Guide by X-Nav Technologies, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081742102XGUIDEPLAN4K | 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 d344001f-4951-40cf-acd4-aca866ef994f 61 fields · synced May 30, 2026
- FDA UDI 0de8a841-b182-4b8d-b327-a0b7d83874fc 36 fields · synced May 30, 2026