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Voluson Expert 22 BT25
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Voluson Expert 22 BT25
Identity
- Trade Name
- Voluson Expert 22 BT25 EUDAMEDVoluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson Expert 18, Voluson Expert 20, Voluson Expert 22 EUDAMEDVoluson Expert 22 BT25 FDA UDI
- Model / Reference
- Voluson Expert 22 BT25 EUDAMEDExpert 22 BT25 FDA UDI
- Description
- Voluson Expert 22 BT25 FDA UDI
Identifiers
- Catalog Number
- 5936104 FDA UDI
- Primary DI / UDI-DI
- 00195278770271 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00372HL EUDAMED
- Direct Marketing DI
- 00195278770271 EUDAMED
- 510(k) Number
- K242168 FDA UDI
- FDA Product Code
- ITY FDA UDIIYO FDA UDIITX 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 I FDA UDI
- Regulation Number
- 892.1760 FDA UDI892.1560 FDA UDI892.1570 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
Voluson Expert 22 BT25 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 |
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Manufacturer
- Manufacturer
- GE Healthcare Austria GmbH & Co OG
- EUDAMED SRN
- AT-MF-000001461
Sources (2)
- EUDAMED 4bcf10b0-fa5a-46e1-b7d5-90bdb6ce978f 61 fields · synced Oct 8, 2026
- FDA UDI e3ba6cd0-dd4d-4809-be1e-3cf0b6e5d3ff 36 fields · synced May 30, 2026