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LOGIQ E10s
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LOGIQ E10s R3R4_R5 UPG / 5946721-5Model LOGIQ E10sRef LOGIQ E10s R3R4_R5 SW UPG Wireless / 5946723-5Ref LOGIQ E10s R4R5_R6 mE UPG / 6003776Ref LOGIQ E10s R5 / 5921403-5Ref LOGIQ E10s R2R3 to R4 SW Upgrade W / 5946723Ref LOGIQ E10s R2R3 to R4 HW Upgrade / 5946722Ref LOGIQ E10s R3 Am / 5860223-20Ref LOGIQ E10s Special Upgrade Kit / 5951946
Identity
- Trade Name
- LOGIQ FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LOGIQ E10s EUDAMEDLOGIQ E10s R2/R3 to R4 SW Upgrade including Wireless FDA UDILOGIQ E10s R2/R3 to R4 Upgrade with Hardware FDA UDI
- Model / Reference
- LOGIQ E10s EUDAMEDLOGIQ E10s R3R4_R5 UPG / 5946721-5 EUDAMEDLOGIQ E10s R3R4_R5 SW UPG Wireless / 5946723-5 EUDAMEDLOGIQ E10s R4R5_R6 mE UPG / 6003776 EUDAMEDLOGIQ E10s R5 / 5921403-5 EUDAMEDLOGIQ E10s R2R3 to R4 SW Upgrade W / 5946723 EUDAMEDLOGIQ E10s R2R3 to R4 HW Upgrade / 5946722 EUDAMEDLOGIQ E10s R3 Am / 5860223-20 EUDAMEDLOGIQ E10s Special Upgrade Kit / 5951946 EUDAMEDE10s R2R3 to R4 SW Upgrade W FDA UDIE10s R2R3 to R4 HW Upgrade FDA UDI
- Description
- LOGIQ E10s R2/R3 to R4 SW Upgrade including Wireless FDA UDILOGIQ E10s R2/R3 to R4 Upgrade with Hardware FDA UDI
Identifiers
- Catalog Number
- 5946723 FDA UDI5946722 FDA UDI
- Primary DI / UDI-DI
- 00198953042755 EUDAMED00198953042762 EUDAMED00198953198667 EUDAMED00198953042793 EUDAMED00195278835772 EUDAMEDFDA UDI00195278835765 EUDAMEDFDA UDI00195278675446 EUDAMED00195278809490 EUDAMED
- Basic UDI-DI
- 8406821BUG00033GT EUDAMED
- 510(k) Number
- K231989 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO 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
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
LOGIQ E10s 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 | 8406821BUG00033GT | 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 (10)
- EUDAMED e9d979cf-63a0-48ab-9573-52a1399ca505 61 fields · synced Sep 17, 2026
- EUDAMED d6a773ec-7d18-4715-a505-caed0ec8affd 61 fields · synced May 18, 2026
- EUDAMED 72d8d7d0-a791-48f9-a07b-93a292191463 61 fields · synced May 18, 2026
- EUDAMED f518defc-4d1c-4eb1-93a5-a9a4001d32b3 61 fields · synced May 18, 2026
- FDA UDI a163b1cb-165b-4067-b2bd-9f7cdd13d718 36 fields · synced May 30, 2026
- FDA UDI 7992d97c-f523-4e80-b28e-e3c3b958cfec 36 fields · synced May 30, 2026
- EUDAMED f8aa76e4-30f5-457a-9741-aa810a4767c3 61 fields · synced Jul 15, 2026
- EUDAMED 12364169-4592-4b49-b44e-6abb30e70f65 61 fields · synced Jul 17, 2026
- EUDAMED f7e3d286-c0ca-4e13-b36e-bb09f110983b 61 fields · synced Jul 21, 2026
- EUDAMED ec12f9ab-3167-40f7-b156-685329e4c5f0 61 fields · synced Jul 24, 2026