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LOGIQ Focus
EUDAMEDClass IIa (EU MDR)
Ref 5984528Model LOGIQ Focus X R1, LOGIQ Focus S R1,
Identity
- Device Name
- LOGIQ Focus EUDAMED
- Model / Reference
- LOGIQ Focus X R1, LOGIQ Focus S R1, EUDAMED5984528 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953043462 EUDAMED
- Basic UDI-DI
- 08406821BUG006327B EUDAMED
- Direct Marketing DI
- 00198953043462 EUDAMED
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Focus 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 | 08406821BUG006327B | 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 905f2577-8c9c-4906-989f-2c41c6dcfda9 61 fields · synced Oct 7, 2026