Identity
- Trade Name
- 21HQ613D EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 21HQ613D-B EUDAMED21HQ613D-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806096102831 EUDAMED08806096102749 EUDAMED08806096367803 EUDAMED08806096102817 EUDAMED08806096367797 EUDAMED
- Basic UDI-DI
- 8806098MONITOR-MAMMONC EUDAMED8806098MNT-2MAMMO46 EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMEDZ11900802 BIOIMAGING 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
21hq613d 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 | K221061 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8806098MONITOR-MAMMONC | 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 8159f237-7321-4a08-86a2-4ae2a4ff13b8 61 fields · synced Aug 1, 2026
- EUDAMED e5e34ecb-ca42-4e55-8e04-0ceb0e628857 61 fields · synced May 17, 2026
- EUDAMED 5cf93ce4-52ca-4de7-a8f3-89c193871278 61 fields · synced May 17, 2026
- EUDAMED 49e1b4bf-7d24-417b-b08a-d69025ba9e3b 61 fields · synced May 17, 2026
- EUDAMED a9ab6c30-8767-4c17-bcfb-f32da4d1e240 61 fields · synced Jul 31, 2026
- FDA 510(k) K221061 1 fields · synced May 18, 2026