Identity
- Trade Name
- LumiGuide Equipment EUDAMEDLumiGuide FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
- Device Name
- AltaTrack Equipment EUDAMEDVisualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected LumiGuide Wire, and of an endovascular catheter, when combined with a LumiGuide 3D Hub. FDA UDI
- Model / Reference
- NCVC933 EUDAMEDLumiGuide Equipment FDA UDI
- Description
- Visualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected LumiGuide Wire, and of an endovascular catheter, when combined with a LumiGuide 3D Hub. FDA UDI
Identifiers
- Catalog Number
- NCVC933 FDA UDI
- Primary DI / UDI-DI
- 00884838112087 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM644TC EUDAMED
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
LumiGuide Equipment by Philips Medical Systems Nederland B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM644TC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 2cc1c1c6-ab8f-40a2-9d3c-941c50936fdf 61 fields · synced Sep 18, 2026
- FDA UDI 147b1f2d-489d-4199-b924-f5e02f6b55de 35 fields · synced May 30, 2026