← Back to catalogue
EPIQ 7 Diagnostic Ultrasound System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 795117Ref 795200
Identity
- Trade Name
- EPIQ 7 Diagnostic Ultrasound System EUDAMEDEPIQ 7 DIAMOND SELECT SYSTEM FDA UDIEPIQ 7G DIAGNOSTIC ULTRASOUND SYSTEM FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- EPIQ Series Diagnostic Ultrasound System EUDAMED
- Model / Reference
- 795117 EUDAMEDFDA UDI795200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838097841 EUDAMEDFDA UDI00884838097865 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM431SR EUDAMED
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN 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
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 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
Yes
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
EPIQ 7 Diagnostic Ultrasound System by Philips Ultrasound 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 | 0884838BM431SR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (4)
- EUDAMED d193cefe-a5aa-45cf-9a53-c45177bb99b1 61 fields · synced Oct 6, 2026
- FDA UDI 9d99d99c-7e36-4ce3-aadf-3b3288ecc2c2 32 fields · synced May 29, 2026
- FDA UDI 5612cca5-c546-4775-ab7d-4a5d4e5a3248 32 fields · synced May 30, 2026
- EUDAMED 4ff8985c-e29f-4cf2-be09-9d6bb2b7d23a 61 fields · synced Jul 12, 2026