Identity
- Trade Name
- 21HK512D EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 21HK512D-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806098613786 EUDAMED08806098575688 EUDAMED08806098575701 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
- Hungary EUDAMEDGermany EUDAMEDNorthern Ireland 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
21hk512d 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 | K191864 | 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 3aad7b28-e05a-4dc7-833b-c06f18987608 61 fields · synced Jul 21, 2026
- EUDAMED 04b40d83-6c75-4de2-868b-10ba6e24810a 61 fields · synced May 18, 2026
- EUDAMED c0c5cc76-6946-486c-bb8d-a91a06e9aa4a 61 fields · synced May 19, 2026
- FDA 510(k) K191864 1 fields · synced May 18, 2026