Identity
- Trade Name
- IPS100A EUDAMEDFSN FDA UDI
- Generic Name
- Video image processor FDA UDI
- Device Name
- Image Processing System EUDAMEDFDA UDI
- Model / Reference
- IPS100A EUDAMEDFDA UDI
- Description
- Image Processing System FDA UDI
Identifiers
- Catalog Number
- IPS100A FDA UDI
- Primary DI / UDI-DI
- 00810000890576 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000089057YJ EUDAMED
- FDA Product Code
- LMD FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Video image processor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2020 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
Ips100a 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 | 081000089057YJ | 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 (2)
- EUDAMED 056df78f-38fd-4180-9ca3-1fb7f4b7dc2e 61 fields · synced Jul 19, 2026
- FDA UDI cba4b9c5-7423-4b1c-a721-f91fe6854af2 35 fields · synced May 30, 2026