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Voluson S8t
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Voluson S8t BT22 / 5881043Model Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6
Identity
- Trade Name
- Voluson S8t EUDAMEDVoluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6 EUDAMEDVoluson S8t BT22 FDA UDI
- Model / Reference
- Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6 EUDAMEDVoluson S8t BT22 / 5881043 EUDAMEDS8t BT22 FDA UDI
- Description
- Voluson S8t BT22 FDA UDI
Identifiers
- Catalog Number
- VOLUSON-S8t-BT22 FDA UDI
- Primary DI / UDI-DI
- 00195278473066 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00209H8 EUDAMED
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS 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
No
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
Voluson S8t by Ge Ultrasound Korea, Ltd. — 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 | 8406821BUG00209H8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Ultrasound Korea, Ltd.
- EUDAMED SRN
- KR-MF-000001860
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 25576932-075a-49c5-9457-674516e4a5e2 61 fields · synced Jul 16, 2026
- FDA UDI 3d753b4d-fef3-4184-a169-3533035ec6a2 37 fields · synced May 30, 2026