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4K Color Display
EUDAMEDFDA UDIClass I (EU MDR)
Ref FM-F3101DRef FM-F2701DRef FM-F3101DG
Identity
- Trade Name
- 4K Color Display EUDAMEDFSN FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- 4K Color Display EUDAMED4K UHD Monitor FDA UDI
- Model / Reference
- FM-F3101D EUDAMEDFM-F2701D EUDAMEDFM-F3101DG EUDAMEDFM-F3101D, FM-F3101DG FDA UDI
- Description
- 4K UHD Monitor FDA UDI
Identifiers
- Catalog Number
- FM-F3101D, FM-F3101DG FDA UDI
- Primary DI / UDI-DI
- 00810000890644 EUDAMED00810000890668 EUDAMED00810000890590 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000089064YF EUDAMED081000089066YK EUDAMED081000089059YN EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
- GMDN Term
- Image display unit, colour FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
4K Color Display by Foreseeson Custom Displays, Inc. — 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 | 081000089064YF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foreseeson Custom Displays Inc.
- EUDAMED SRN
- US-MF-000012443
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (4)
- EUDAMED 1a84d2f3-9d14-4250-9ec4-1688c7d500d8 61 fields · synced Jul 22, 2026
- EUDAMED 048f71c2-bd2d-4802-a5ba-81f0fe1171cd 61 fields · synced May 17, 2026
- EUDAMED b729ae23-3c36-4b8d-aeae-c0c28d1eb94c 61 fields · synced May 18, 2026
- FDA UDI 0fb4a49d-cd21-427b-bb0d-c4e9e02554f6 34 fields · synced May 30, 2026