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EPIQ Elite Diagnostic Ultrasound System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 795234
Identity
- Trade Name
- EPIQ Elite Diagnostic Ultrasound System EUDAMEDFDA 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
- 795234 EUDAMEDFDA UDI
- Description
- Software version- 10.0.X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838114159 EUDAMEDFDA UDI00884838128125 EUDAMED
- Basic UDI-DI
- 0884838BM431SR EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDIOBJ FDA UDIQIH 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
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI870.1200 FDA UDI892.2050 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
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
MR Unsafe FDA UDI
EPIQ Elite 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 |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED fa10ef97-bb0c-4c09-9744-67bc85f8ad1d 61 fields · synced Oct 6, 2026
- EUDAMED e4caaca0-ef50-4fa5-954e-f6ca5f2a54e9 61 fields · synced May 19, 2026
- FDA UDI d4834f00-c131-420a-8fe2-8ce39d7aedc6 33 fields · synced May 30, 2026