Identity
- Trade Name
- 21HQ513D EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 21HQ513D-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806096367858 EUDAMED
- Basic UDI-DI
- 8806098MNT-2DIAGNOSE86 EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS 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
21hq513d by LG Electronics Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K212295 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K223789 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8806098MNT-2DIAGNOSE86 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- EUDAMED SRN
- KR-MF-000001897
- FDA Applicant
- Lg Electronics.Inc
- Authorised Representative
- LG Electronics Deutchland GmbH DE-AR-000044729
Sources (2)
- EUDAMED 4787b914-797c-47cf-bd93-5850b6be7386 85 fields · synced Jun 19, 2026
- FDA 510(k) K212295 1 fields · synced May 18, 2026