Identity
- Trade Name
- Image Processing System EUDAMED
- Device Name
- Image Processing System EUDAMED
- Model / Reference
- IPS1000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810000890293 EUDAMED
- Basic UDI-DI
- 081000089029YD EUDAMED
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Image Processing System by Foreseeson Custom Displays, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081000089029YD | Class I | Active |
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Manufacturer
- Manufacturer
- Foreseeson Custom Displays Inc.
- EUDAMED SRN
- US-MF-000012443
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED b22b906a-6f33-4731-bcb3-3a6706496086 61 fields · synced Jun 18, 2026