EPIQ 7W Diagnostic Ultrasound System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EPIQ 7 Diagnostic Ultrasound System EUDAMEDEPIQ 7W Diagnostic Ultrasound System FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- EPIQ Series Diagnostic Ultrasound System EUDAMEDSoftware version - 10.0.x FDA UDI
- Model / Reference
- 795202 EUDAMEDFDA UDI
- Description
- Software version - 10.0.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838114104 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM431SR EUDAMED
- FDA Product Code
- QIH FDA UDIIYN FDA UDIIYO FDA UDIITX FDA UDIOBJ FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI870.1200 FDA UDI
- Market of Registration
- Germany EUDAMED
- 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
Yes
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
No
Category: General-purpose ultrasound imaging system
EPIQ 7W Diagnostic Ultrasound System by Philips Ultrasound LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
Sources (2)
- FDA UDI d3cd9358-70cc-406d-a610-ce0d6f4a8398 33 fields · synced Oct 7, 2026
- EUDAMED 6d0d2b3d-f808-400f-8489-723ef08cb6b5 61 fields · synced Oct 6, 2026