Identity
- Trade Name
- 32HL512D EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 32HL512D-B EUDAMED32HL512D-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806098639441 EUDAMED08806096367896 EUDAMED08806098606382 EUDAMED08806098750009 EUDAMED08806096367889 EUDAMED
- Basic UDI-DI
- 8806098MONITOR-DIAGNOSEKY EUDAMED8806098MNT-2DIAGNOSE86 EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa 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
32hl512d 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 | K192925 | 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 (6)
- EUDAMED 537ba368-a75e-40c0-ae7f-906bcf5e83be 61 fields · synced Aug 1, 2026
- EUDAMED 6cd26902-e1e6-40ec-9d01-d38ece793a55 61 fields · synced May 17, 2026
- EUDAMED 92078846-f4c8-4305-86ef-a04a04d655c3 61 fields · synced Jul 12, 2026
- EUDAMED a5044a53-8608-407c-8742-7d25ea6ea6ff 61 fields · synced Jul 13, 2026
- EUDAMED 9d746497-6615-4c86-ba92-3f86cfff3499 61 fields · synced Aug 1, 2026
- FDA 510(k) K192925 1 fields · synced May 18, 2026