Logiq E10
by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC United States EUDAMEDGUDID
Ref 5969829Model LOGIQ E10
Product code IYNEMDN Z11040104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00195278942241 | Date5 Dec 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number8406821BUG00028H2 | Date2 May 2023 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Logiq E10 EUDAMEDLogiq GUDID
- Generic Name
- General-purpose ultrasound imaging system
- Model / Ref / Catalog
- LOGIQ E10 EUDAMED5969829 EUDAMEDE10 R2R3 to R4 UPG GUDID5699829 GUDID
- Primary DI / UDI-DI
- 00195278942241
- Basic UDI-DI
- 8406821BUG00028H2
- FDA Product Code
- IYN, IYO, ITX
- EMDN Code
- Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
- GMDN Term
- General-purpose ultrasound imaging system
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1550, 892.1560, 892.1570
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | LOGIQ E10 5969829 | E10 R2R3 to R4 UPG |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000016119
- Authorised representative
- GE Medical Systems SCS FR-AR-000000344
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Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED c9d7e32a-d52d-4175-8668-d3e13e0b1716
- FDA UDI 84e1b0d4-a36f-42e6-b59a-5fe1205272bf