Identity
- Trade Name
- LM2-18 EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- Ultrasound probe EUDAMEDN/A EUDAMEDUSP-L02IFXA/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809725796647 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972578USP001WH EUDAMED
- 510(k) Number
- K220269 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX 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
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Netherlands 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
No
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
Lm2-18 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 2cd58384-4e29-497c-b76c-9d4ee08a1bd0 61 fields · synced Oct 6, 2026
- FDA UDI 59046e20-98ae-4e61-92ea-514e7c6982ff 33 fields · synced May 30, 2026