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Voluson P8, Voluson P6
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Voluson Performance to BT22 UPG / 5881175Model Voluson P8, Voluson P6
Identity
- Trade Name
- Voluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson P8, Voluson P6 EUDAMEDVoluson Performance to BT22 UPG FDA UDI
- Model / Reference
- Voluson P8, Voluson P6 EUDAMEDVoluson Performance to BT22 UPG / 5881175 EUDAMEDPerformance to BT22 UPG FDA UDI
- Description
- Voluson Performance to BT22 UPG FDA UDI
Identifiers
- Catalog Number
- Voluson-Performance-to-BT22-UPG FDA UDI
- Primary DI / UDI-DI
- 00195278473011 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00210GR EUDAMED
- FDA Product Code
- IYN FDA UDIIYO 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
- 892.1550 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
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 P8, Voluson P6 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 | 8406821BUG00210GR | 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 77614cf1-8967-402d-afe0-5be9242a022a 61 fields · synced Jul 15, 2026
- FDA UDI 6b001df2-6dee-424d-aa7f-bebf3ae41577 36 fields · synced May 30, 2026