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Voluson Performance 16
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Voluson Performance 16 / 5957171Model Voluson Performance 18, Voluson Performance 16
Identity
- Trade Name
- Voluson Performance 16 EUDAMEDVoluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson Performance 16 FDA UDI
- Model / Reference
- Voluson Performance 18, Voluson Performance 16 EUDAMEDVoluson Performance 16 / 5957171 EUDAMEDPerformance 16 FDA UDI
- Description
- Voluson Performance 16 FDA UDI
Identifiers
- Catalog Number
- H43532LS FDA UDI
- Primary DI / UDI-DI
- 00195278910493 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG005126Y EUDAMED
- 510(k) Number
- K250543 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDIQIH 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 UDI892.1550 FDA UDI892.1560 FDA UDI892.2050 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
MR Unsafe FDA UDI
Voluson Performance 16 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 | 08406821BUG005126Y | 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 f1cec755-714e-44f6-86b1-af226e2cc2d0 61 fields · synced Jul 26, 2026
- FDA UDI 647a3557-3a2e-47ef-9283-5f98616a626d 36 fields · synced May 30, 2026