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32hq713d
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 32HQ713D-B510(k) K223423Ref 32HQ713D-M
Identity
- Trade Name
- 32HQ713D EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 32HQ713D-B EUDAMED32HQ713D-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806084040497 EUDAMED08806096367872 EUDAMED08806084040541 EUDAMED08806084040473 EUDAMED08806096367827 EUDAMED
- Basic UDI-DI
- 8806098MONITOR-MAMMONC EUDAMED8806098MNT-2MAMMO46 EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMEDHungary 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
32hq713d 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 | K223423 | 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
- FDA Applicant
- Lg Electronics.Inc
- Authorised Representative
- LG Electronics Deutchland GmbH DE-AR-000044729
Sources (6)
- EUDAMED b7fc713a-4e2f-4e8f-a883-e3d04e516864 85 fields · synced Jul 24, 2026
- EUDAMED 2c2abfe1-d9ce-4415-bef0-7142d7c0543f 61 fields · synced May 18, 2026
- EUDAMED 7379a852-c988-49fa-9a8c-32e953134ff3 61 fields · synced Jul 8, 2026
- EUDAMED 84a2e300-d89a-4ab9-aa1d-8a811c8cf267 61 fields · synced Jul 23, 2026
- EUDAMED db47d40c-a0e0-4ee6-b35b-ab3f8d3acab4 61 fields · synced Jul 24, 2026
- FDA 510(k) K223423 1 fields · synced May 18, 2026