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LCD Monitor [
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref S8420SModel Medical MonitorRef R241MRef E190DHGRef S5810Ref E550EGRef E550DGRef E270AGRef S9820Ref M270G510(k) K151972Ref CR240G
Identity
- Trade Name
- LCD Monitor [ EUDAMEDLCD Monitor EUDAMED
- Device Name
- Medical Monitor EUDAMED
- Model / Reference
- Medical Monitor EUDAMEDS8420S EUDAMEDR241M EUDAMEDE190DHG EUDAMEDS5810 EUDAMEDE550EG EUDAMEDE550DG EUDAMEDE270AG EUDAMEDS9820 EUDAMEDM270G EUDAMEDCR240G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971553200480 EUDAMED06971553200411 EUDAMED06971553200497 EUDAMED06971553200466 EUDAMED06971553200534 EUDAMED06971553200527 EUDAMED06971553200503 EUDAMED06971553200473 EUDAMED06971553200275 EUDAMED06971553200008 EUDAMED
- Basic UDI-DI
- 697155320MONITOR2T EUDAMED
- Direct Marketing DI
- 06971553200480 EUDAMED06971553200411 EUDAMED06971553200497 EUDAMED06971553200466 EUDAMED06971553200534 EUDAMED06971553200527 EUDAMED06971553200503 EUDAMED06971553200473 EUDAMED06971553200275 EUDAMED06971553200008 EUDAMED
- 510(k) Number
- K151972 FDA 510(k)
- FDA Product Code
- PGY FDA 510(k)
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Market of Registration
- Poland EUDAMEDFrance EUDAMEDGreece EUDAMEDItaly EUDAMEDGermany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
LCD Monitor [ by Nanjing Jusha Display Technology Co., Ltd. — 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 | K151972 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697155320MONITOR2T | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Jusha Display Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027215
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (11)
- EUDAMED 3d837eb7-57eb-4697-bc80-b1b74afc6e8d 61 fields · synced Jul 30, 2026
- EUDAMED ad86d31d-4887-4ce8-9a2f-9926de39a737 61 fields · synced May 11, 2026
- EUDAMED b975c312-6a84-4121-9dda-9e3e0af4d7be 61 fields · synced May 11, 2026
- EUDAMED 7de5940c-153d-4a1f-9b20-c1f68c1708bf 61 fields · synced May 16, 2026
- EUDAMED dbb8d0d7-fcf1-4cee-8702-9ab8884bd751 61 fields · synced May 17, 2026
- EUDAMED 54686f97-4b77-4b89-9fb5-a1262bcc42d4 61 fields · synced May 17, 2026
- EUDAMED 880232cf-9930-477b-a1ca-b8dde1cf1be7 61 fields · synced May 17, 2026
- EUDAMED 654460f0-2f71-4204-84e6-03d9f8e918c6 61 fields · synced May 18, 2026
- EUDAMED 18357f99-5ec2-4680-91bf-26733ec2cc70 61 fields · synced May 18, 2026
- FDA 510(k) K151972 24 fields · synced May 18, 2026
- EUDAMED 31c789f4-6b59-4068-9d13-5b53d1d8f40c 61 fields · synced Jul 30, 2026