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LOGIQ Totus, LOGIQ Totus HDU
EUDAMEDClass IIa (EU MDR)
Ref LOGIQ Totus R5 SW upgrade / 9687264 Model LOGIQ Totus
Identity
- Device Name
- LOGIQ Totus, LOGIQ Totus HDU EUDAMED
- Model / Reference
- LOGIQ Totus EUDAMEDLOGIQ Totus R5 SW upgrade / 9687264 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953113493 EUDAMED
- Basic UDI-DI
- 8406821BUG00347HM 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 Totus, LOGIQ Totus HDU 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 | 8406821BUG00347HM | 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 72a7bca8-8947-49ae-adc3-824901d4df38 61 fields · synced Jun 19, 2026