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LOGIQ Fortis
EUDAMEDClass IIa (EU MDR)
Ref LOGIQ Fortis R3-R5 SW & HW Upgrade / 5946726-5Model LOGIQ Fortis
Identity
- Device Name
- LOGIQ Fortis EUDAMED
- Model / Reference
- LOGIQ Fortis EUDAMEDLOGIQ Fortis R3-R5 SW & HW Upgrade / 5946726-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953109465 EUDAMED
- Basic UDI-DI
- 8406821BUG00214GZ EUDAMED
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LOGIQ Fortis by Ge Ultrasound Korea, Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00214GZ | Class IIa | Active |
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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 (1)
- EUDAMED 386eeb41-34fd-4b55-b9f4-d52ef0301d26 61 fields · synced May 25, 2026