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LOGIQ Fortis
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LOGIQ Fortis R3-R5 SW & WiFi Upgrade / 5946727-5Model LOGIQ FortisRef LOGIQ Fortis R5 SW Upgrade / 5946725-5Ref LOGIQ Fortis R4 to R5 UPG / 5962803Ref LOGIQ Fortis R5 LCD / 6601000-5Ref LOGIQ Fortis R5 HDU / 6602000-5Ref LOGIQ Fortis R3 to R4 SW Upgrade W / 5946727Ref LOGIQ Fortis R3 to R4 UPG / 5927390Ref LOGIQ Fortis R3-R5 SW, HW & WiFi Upgrade / 5946728-5Ref LOGIQ Fortis LCD / 6601000Ref LOGIQ Fortis R3 to R4 HW Upgrade / 5946726
Identity
- Trade Name
- LOGIQ FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LOGIQ Fortis EUDAMEDLOGIQ Fortis LCD Console FDA UDILOGIQ Fortis R3 to R4 SW Upgrade including Wireless FDA UDILOGIQ Fortis R3 to R4 Upgrade with Hardware FDA UDI
- Model / Reference
- LOGIQ Fortis EUDAMEDLOGIQ Fortis R3-R5 SW & WiFi Upgrade / 5946727-5 EUDAMEDLOGIQ Fortis R5 SW Upgrade / 5946725-5 EUDAMEDLOGIQ Fortis R4 to R5 UPG / 5962803 EUDAMEDLOGIQ Fortis R5 LCD / 6601000-5 EUDAMEDLOGIQ Fortis R5 HDU / 6602000-5 EUDAMEDLOGIQ Fortis R3 to R4 SW Upgrade W / 5946727 EUDAMEDLOGIQ Fortis R3 to R4 UPG / 5927390 EUDAMEDLOGIQ Fortis R3-R5 SW, HW & WiFi Upgrade / 5946728-5 EUDAMEDLOGIQ Fortis LCD / 6601000 EUDAMEDLOGIQ Fortis R3 to R4 HW Upgrade / 5946726 EUDAMEDFORTIS LCD FDA UDIFortis R3 to R4 SW Upgrade W FDA UDIFortis R3 to R4 HW Upgrade FDA UDI
- Description
- LOGIQ Fortis LCD Console FDA UDILOGIQ Fortis R3 to R4 SW Upgrade including Wireless FDA UDILOGIQ Fortis R3 to R4 Upgrade with Hardware FDA UDI
Identifiers
- Catalog Number
- 5946727 FDA UDI5946726 FDA UDI
- Primary DI / UDI-DI
- 00198953109458 EUDAMED00198953109434 EUDAMED00195278877130 EUDAMED00198953109403 EUDAMED00198953109410 EUDAMED00195278405333 EUDAMEDFDA UDI00195278835734 EUDAMEDFDA UDI00195278835802 EUDAMEDFDA UDI00195278627056 EUDAMED00198953109427 EUDAMED
- Basic UDI-DI
- 8406821BUG00214GZ EUDAMED
- Direct Marketing DI
- 00195278405333 EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX 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 UDI892.1550 FDA UDI892.1570 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 UDIFDA 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 (13)
- EUDAMED 0a8ed172-02b2-4dc1-91c3-5f601c377458 61 fields · synced Oct 6, 2026
- EUDAMED d7498f50-4444-4f9d-ba1f-bb7c1eccf9a4 61 fields · synced May 16, 2026
- EUDAMED b6756a30-b603-4313-b732-2e36ca2a382c 61 fields · synced May 16, 2026
- EUDAMED e3927543-eb48-4789-954b-4b3cdb9df547 61 fields · synced May 18, 2026
- EUDAMED 91cd070f-7c99-4152-a262-43993d8d1883 61 fields · synced May 18, 2026
- FDA UDI e851d1c9-d28c-46d6-9e09-46d2463c3323 36 fields · synced May 27, 2026
- FDA UDI 6a8a4b42-c95c-4bc6-9c61-bef7405bf9ac 36 fields · synced May 30, 2026
- FDA UDI 40cb89e7-9738-45f5-b14e-e22380d28ad3 36 fields · synced May 30, 2026
- EUDAMED a5d87091-d6de-4137-a5cd-3761287c429b 61 fields · synced Jul 9, 2026
- EUDAMED 878756d6-ad6f-46b1-8e1f-dcdd34ae66bf 61 fields · synced Jul 13, 2026
- EUDAMED 1bf8085f-5f58-4f1b-be5f-3e887c448f59-1 61 fields · synced Jul 14, 2026
- EUDAMED 2d7e431e-6e3a-403f-b7aa-8a3b7daa6ce3 61 fields · synced Jul 15, 2026
- EUDAMED 2f5fee81-7143-4fdc-801a-6aa4b319a8d6 61 fields · synced Aug 2, 2026