Identity
- Trade Name
- Ultrasound Workspace EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Ultrasound Workspace EUDAMEDDevice Model: 300013759461 FDA UDI
- Model / Reference
- 300013759461 EUDAMED7.0.0.0 FDA UDI6.0.2.0 FDA UDI
- Description
- Device Model: 300013759461 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838125186 EUDAMEDFDA UDI00884838129276 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1735MX EUDAMED
- Direct Marketing DI
- 00884838125186 EUDAMED00884838129276 EUDAMED
- 510(k) Number
- K241659 FDA UDI
- FDA Product Code
- QIH FDA UDILLZ FDA UDIIYN FDA UDI
- EMDN Code
- Z11049092 VARIOUS ULTRASOUND INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ultrasound Workspace 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 | 0884838BM1735MX | 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 (4)
- EUDAMED 5e1f8aca-bfbe-4063-963b-c4127b71050e 61 fields · synced Oct 6, 2026
- FDA UDI ec83459c-cbe6-4cd8-9a10-9c66666e2c9f 34 fields · synced May 30, 2026
- FDA UDI 7162f9b1-3f32-461a-931a-508881b2dc3c 33 fields · synced May 30, 2026
- EUDAMED 38ec87c2-f03e-4a37-a3d6-b7111c053091 61 fields · synced Jul 9, 2026