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Flash Ultrasound System 5100 POC
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 795404Model Flash Ultrasound System 5100 POC
Identity
- Trade Name
- Flash Ultrasound System 5100 POC EUDAMEDUltrasound System 5100 POC Pro FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Ultrasound System 5100 POC EUDAMEDFlash Ultrasound System 5100 POC, release 1.0. FDA UDI
- Model / Reference
- Flash Ultrasound System 5100 POC EUDAMED795404 EUDAMEDFDA UDI
- Description
- Flash Ultrasound System 5100 POC, release 1.0. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838120174 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1163M6 EUDAMED
- 510(k) Number
- K250030 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Market of Registration
- Austria 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
Flash Ultrasound System 5100 POC 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 | 0884838BM1163M6 | 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 (2)
- EUDAMED 7ee45772-a545-4812-89e1-106fca51275b 61 fields · synced Oct 6, 2026
- FDA UDI 71523ebb-aa47-4762-a912-9f86f0bc1e71 34 fields · synced May 30, 2026