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LOGIQ E10s
EUDAMEDClass IIa (EU MDR)
Ref LOGIQ E10s Special Upgrade Kit / 5951946Model LOGIQ E10s
Identity
- Device Name
- LOGIQ E10s EUDAMED
- Model / Reference
- LOGIQ E10s EUDAMEDLOGIQ E10s Special Upgrade Kit / 5951946 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278809490 EUDAMED
- Basic UDI-DI
- 8406821BUG00033GT EUDAMED
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa 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 E10s by Ge Ultrasound Korea, Ltd. — Class IIa — CE/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 | 8406821BUG00033GT | 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 ec12f9ab-3167-40f7-b156-685329e4c5f0 61 fields · synced Oct 6, 2026