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LCD Monitor
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref JUSHA-M53Model Medical Monitor
Identity
- Trade Name
- LCD Monitor EUDAMEDJUSHA FDA UDI
- Generic Name
- Image display unit, monochrome FDA UDI
- Device Name
- Medical Monitor EUDAMEDLCD Monitor FDA UDI
- Model / Reference
- Medical Monitor EUDAMEDJUSHA-M53 EUDAMEDFDA UDI
- Description
- LCD Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971553200145 EUDAMEDFDA UDI
- Basic UDI-DI
- 697155320MONITOR2T EUDAMED
- Direct Marketing DI
- 06971553200145 EUDAMED
- FDA Product Code
- PGY FDA UDI
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
- GMDN Term
- Image display unit, monochrome FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Italy 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
Yes
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 | K150842 | 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 (3)
- EUDAMED 6713e5e8-5efa-476f-9c6b-a1989797fa95 61 fields · synced Jun 20, 2026
- FDA UDI 5e123352-6388-427d-9010-f92431efb91b 33 fields · synced May 30, 2026
- FDA 510(k) K150842 1 fields · synced May 18, 2026