← Back to catalogue
VolusonExp BT24 to BT25 UPG
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VolusonExp BT24 to BT25 UPG
Identity
- Trade Name
- VolusonExp BT24 to BT25 UPG EUDAMEDVoluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson Expert 18, Voluson Expert 20, Voluson Expert 22 EUDAMEDVolusonExp BT24 to BT25 UPG FDA UDI
- Model / Reference
- VolusonExp BT24 to BT25 UPG EUDAMEDExp BT24 to BT25 UPG FDA UDI
- Description
- VolusonExp BT24 to BT25 UPG FDA UDI
Identifiers
- Catalog Number
- 5954291 FDA UDI
- Primary DI / UDI-DI
- 00195278814685 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00372HL EUDAMED
- Direct Marketing DI
- 00195278814685 EUDAMED
- 510(k) Number
- K242168 FDA UDI
- 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
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VolusonExp BT24 to BT25 UPG by GE Healthcare Austria GmbH & Co OG — 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 | 8406821BUG00372HL | 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
- GE Healthcare Austria GmbH & Co OG
- EUDAMED SRN
- AT-MF-000001461
Sources (2)
- EUDAMED 654188bd-7f85-42f0-9aab-1eea86a24e8c 61 fields · synced Oct 7, 2026
- FDA UDI 27484fac-67bc-4068-94f6-268b14163142 35 fields · synced May 30, 2026