Identity
- Trade Name
- 24HR513C EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 24HR513C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806084067746 EUDAMED08806084068453 EUDAMED08806084067692 EUDAMED
- Basic UDI-DI
- 8806098MONITOR-DIAGNOSEKY EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDHungary EUDAMEDGermany 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
24hr513c by LG Electronics Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232985 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8806098MONITOR-DIAGNOSEKY | Class I | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- EUDAMED SRN
- KR-MF-000001897
- Authorised Representative
- LG Electronics Deutchland GmbH DE-AR-000044729
Sources (4)
- EUDAMED 3769f943-ee1d-46e1-9040-72646bb6a478 61 fields · synced Jul 20, 2026
- EUDAMED 0750e0d0-f309-4d9c-8af5-8386b6a44479 61 fields · synced May 17, 2026
- EUDAMED 365671d8-5466-463f-b2f5-dfdb8f4d3773 61 fields · synced May 19, 2026
- FDA 510(k) K232985 1 fields · synced May 18, 2026