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 EUDAMEDR190 EUDAMEDFDA UDI
- Description
- LCD Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971553200169 EUDAMEDFDA UDI
- Basic UDI-DI
- 697155320MONITOR2T EUDAMED
- Direct Marketing DI
- 06971553200169 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
- Germany 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697155320MONITOR2T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 894fa553-9cd8-4774-be20-8ce90d1c05a6 61 fields · synced May 30, 2026
- FDA UDI f1d45fdc-f2f1-4587-b67f-2b91737ea9a8 33 fields · synced May 30, 2026