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LOGIQ Fortis
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LOGIQ Fortis R3 to R4 HW Upgrade W / 5946728Model LOGIQ Fortis
Identity
- Trade Name
- LOGIQ FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LOGIQ Fortis EUDAMEDLOGIQ Fortis R3 to R4 Upgrade with Hardware including Wireless FDA UDI
- Model / Reference
- LOGIQ Fortis EUDAMEDLOGIQ Fortis R3 to R4 HW Upgrade W / 5946728 EUDAMEDFortis R3 to R4 HW Upgrade W FDA UDI
- Description
- LOGIQ Fortis R3 to R4 Upgrade with Hardware including Wireless FDA UDI
Identifiers
- Catalog Number
- 5946728 FDA UDI
- Primary DI / UDI-DI
- 00195278835758 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00214GZ EUDAMED
- 510(k) Number
- K231989 FDA UDI
- 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
LOGIQ Fortis 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 | 8406821BUG00214GZ | 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 cc04c4ca-f42c-4b8b-ab3f-ba9c3dbb6e26 61 fields · synced Jul 27, 2026
- FDA UDI 9be47af3-0858-4837-9e06-39c9f46bf6c0 36 fields · synced May 30, 2026