Identity
- Trade Name
- LA2-16Sc EUDAMED
- Model / Reference
- Ultrasound probe EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800290032710 EUDAMED
- Basic UDI-DI
- 880972578USP001WH EUDAMED
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Extracorporeal ultrasound imaging transducer, hand-held
LA2-16Sc by Samsung Medison Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880972578USP001WH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Samsung Medison Co., Ltd
- EUDAMED SRN
- KR-MF-000011620
- Authorised Representative
- Samsung Electronics GmbH DE-AR-000007005
Sources (1)
- EUDAMED 74a56959-15f5-4d4a-bc17-b15d1448d8e9 61 fields · synced Oct 6, 2026