Identity
- Trade Name
- 21HQ513D EUDAMEDLG FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 21HQ513D-G EUDAMED21HQ513D FDA UDI
Identifiers
- Catalog Number
- 21HQ513D-G FDA UDI
- Primary DI / UDI-DI
- 08806096660263 EUDAMEDFDA UDI
- Basic UDI-DI
- 8806098MONITOR-DIAGNOSEKY EUDAMED
- 510(k) Number
- K212295 FDA UDI
- FDA Product Code
- PGY FDA UDI
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
- GMDN Term
- Image display unit, colour FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
21hq513d by LG Electronics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8806098MONITOR-DIAGNOSEKY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- EUDAMED SRN
- KR-MF-000001897
- Authorised Representative
- LG Electronics Deutchland GmbH DE-AR-000044729
Sources (2)
- EUDAMED fcd68874-f38e-4505-9a62-eede0c4a7b52 61 fields · synced Jul 17, 2026
- FDA UDI d31312db-1622-4194-bfa8-059eb1e5612a 34 fields · synced May 30, 2026