Identity
- Trade Name
- LA4-18B EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- Ultrasound probe EUDAMEDN/A EUDAMEDUSP-L04IF4B/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809702986740 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972578USP001WH EUDAMED
- 510(k) Number
- K163691 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Extracorporeal ultrasound imaging transducer, hand-held
La4-18b by Samsung Medison Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880972578USP001WH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Samsung Medison Co., Ltd
- EUDAMED SRN
- KR-MF-000011620
- Authorised Representative
- Samsung Electronics GmbH DE-AR-000007005
Sources (2)
- EUDAMED 6b86c3fc-90c4-4ed8-9dda-cc1c06c80814 61 fields · synced Oct 6, 2026
- FDA UDI 3b7a006d-a746-4370-b008-aab4f60cd123 33 fields · synced May 29, 2026