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-A5504DG, FM-A5504DS EUDAMEDFM-A5504DS, FM-A5504DG FDA UDI
- Description
- 4K UHD Monitor FDA UDI
Identifiers
- Catalog Number
- FM-A5504DS, FM-A5504DG FDA UDI
- Primary DI / UDI-DI
- 00810000890347 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000089034Y6 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 | 081000089034Y6 | 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 (3)
- EUDAMED 345d5a77-2220-4cf1-94bd-1177825a74fc 61 fields · synced Jun 19, 2026
- FDA UDI 1eaf727c-e8bd-42b7-95b1-86f6b069f464 35 fields · synced May 27, 2026
- EUDAMED 345d5a77-2220-4cf1-94bd-1177825a74fc-1 61 fields · synced Jun 9, 2026