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LCD Monitor
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref E240AGModel Medical Monitor510(k) K190831Ref C820G
Identity
- Trade Name
- LCD Monitor EUDAMEDJUSHA FDA UDI
- Generic Name
- Endoscopic video image display unit FDA UDI
- Device Name
- Medical Monitor EUDAMEDLCD Monitor FDA UDI
- Model / Reference
- Medical Monitor EUDAMEDE240AG EUDAMEDFDA UDIC820G EUDAMED
- Description
- LCD Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971553200220 EUDAMEDFDA UDI06971553200442 EUDAMED
- Basic UDI-DI
- 697155320MONITOR2T EUDAMED
- Direct Marketing DI
- 06971553200220 EUDAMED06971553200442 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
- GMDN Term
- Endoscopic video image display unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMEDItaly 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
LCD Monitor by Nanjing Jusha Display Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K190831 | 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 (4)
- EUDAMED 01a639f5-7d59-4b7b-bdd0-ed169f883e7f 85 fields · synced Jul 15, 2026
- EUDAMED 89cd6b39-637f-42e5-bd38-841101802f9a 61 fields · synced May 18, 2026
- FDA UDI 33dca229-7caf-4c8a-b9d8-9032ece15b67 33 fields · synced May 30, 2026
- FDA 510(k) K190831 1 fields · synced May 18, 2026