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Voluson P8, Voluson P6
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Voluson P8 BT22 / 5882489Model 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 P8 BT22 FDA UDI
- Model / Reference
- Voluson P8, Voluson P6 EUDAMEDVoluson P8 BT22 / 5882489 EUDAMEDP8 BT22 FDA UDI
- Description
- Voluson P8 BT22 FDA UDI
Identifiers
- Catalog Number
- VOLUSON-P8-BT22 FDA UDI
- Primary DI / UDI-DI
- 00195278473103 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00210GR EUDAMED
- FDA Product Code
- IYO FDA UDIITX 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
- 892.1560 FDA UDI892.1570 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 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 bc594130-ebb6-4926-846f-03eb775faca8 61 fields · synced Jul 10, 2026
- FDA UDI bfde76fd-1cd8-4e57-9d57-ff3cf4e5c212 37 fields · synced May 29, 2026