Identity
- Trade Name
- UroNav EUDAMEDFDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- UroNav 4 EUDAMEDUroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. FDA UDI
- Model / Reference
- UroNav 4 EUDAMEDFDA UDI784039 EUDAMED
- Description
- UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. FDA UDI
Identifiers
- Catalog Number
- 784039 FDA UDI
- Primary DI / UDI-DI
- 00884838107069 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM419T3 EUDAMED
- FDA Product Code
- LLZ FDA UDIQTZ FDA UDI
- EMDN Code
- Z11040182 ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
UroNav by Philips DS North America LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250800 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM419T3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Philips DS North America LLC
- EUDAMED SRN
- US-MF-000035802
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED ffd4760b-b525-4831-8208-c403769047ea 61 fields · synced Jun 18, 2026
- FDA UDI 107d1cd3-72ef-4544-9700-57c154ef635a 35 fields · synced May 30, 2026
- FDA 510(k) K250800 1 fields · synced May 18, 2026