Identity
- Trade Name
- LOGIQ EUDAMED
- Device Name
- LOGIQ e EUDAMED
- Model / Reference
- LOGIQ e EUDAMEDLOGIQ e R10 UPG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953147351 EUDAMED
- Basic UDI-DI
- 8406821BUG00379J2 EUDAMED
- Direct Marketing DI
- 00198953147351 EUDAMED
- EMDN Code
- Z11040103 PORTABLE 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 by GE Medical Systems CO. 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 | 8406821BUG00379J2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED bff21604-33b6-4f57-b5b7-1198fb2ee32a 61 fields · synced May 23, 2026