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Logiq P8, Logiq P9, Logiq P10
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LP10 R4 to R4.5 SW Conversion/H43012LGModel LOGIQ P8, LOGIQ P9, LOGIQ P10
Identity
- Trade Name
- LOGIQ FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LOGIQ P8, LOGIQ P9, LOGIQ P10 EUDAMEDLP10 R4 to R4.5 SW Conversion FDA UDI
- Model / Reference
- LOGIQ P8, LOGIQ P9, LOGIQ P10 EUDAMEDLP10 R4 to R4.5 SW Conversion/H43012LG EUDAMEDP10 R4 to R4.5 SW Conversion FDA UDI
- Description
- LP10 R4 to R4.5 SW Conversion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278464620 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00211GT EUDAMED
- 510(k) Number
- K214039 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Logiq P8, Logiq P9, Logiq P10 by Ge Ultrasound Korea, Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00211GT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED c7813144-7bc5-4310-9ff6-f06270054843 61 fields · synced Jun 18, 2026
- FDA UDI fd32e461-325c-4675-ba4b-1aec64065424 35 fields · synced May 30, 2026