Identity
- Trade Name
- 55MH5K EUDAMED
- Device Name
- MEDICAL MONITOR EUDAMED
- Model / Reference
- 55MH5K-W EUDAMED55MH5K-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806087070088 EUDAMED08806096418055 EUDAMED08806096418062 EUDAMED
- Basic UDI-DI
- 8806098MONITOR-SURGICAL62 EUDAMED
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
55mh5k by LG Electronics Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8806098MONITOR-SURGICAL62 | 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 (3)
- EUDAMED 573fe769-9f4f-4907-b5e7-2de508fe15f8 61 fields · synced Aug 4, 2026
- EUDAMED cfc38e41-4b46-4e2f-a1a4-e15455ef9e01 61 fields · synced May 17, 2026
- EUDAMED 14e53167-becc-4c0d-a91e-44019d679a22 61 fields · synced May 17, 2026