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Voluson Expert 18, Voluson Expert 20, Voluson Expert 22
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Voluson Exp to BT24 UPG
Identity
- Trade Name
- Voluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson Expert 18, Voluson Expert 20, Voluson Expert 22 EUDAMEDVoluson Exp to BT24 UPG FDA UDI
- Model / Reference
- Voluson Exp to BT24 UPG EUDAMEDExp to BT24 UPG FDA UDI
- Description
- Voluson Exp to BT24 UPG FDA UDI
Identifiers
- Catalog Number
- 5936797 FDA UDI
- Primary DI / UDI-DI
- 00195278677587 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00372HL EUDAMED
- Direct Marketing DI
- 00195278677587 EUDAMED
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO 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 UDI892.1570 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Voluson Expert 18, Voluson Expert 20, Voluson Expert 22 by GE Healthcare Austria GmbH & Co OG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 (3)
- EUDAMED 19d011e9-1206-4490-bac2-2fda2a80be99 61 fields · synced Oct 8, 2026
- FDA UDI 8d025d10-a3af-4778-ba34-67eea99168f2 36 fields · synced May 27, 2026
- EUDAMED a7ee2971-2661-4d0b-a240-203322d499a4 61 fields · synced Jun 18, 2026