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Image Processing System
EUDAMEDClass I (EU MDR)
Ref MTS800ARef IPS710ARef IPS1001A
Identity
- Trade Name
- Image Processing System EUDAMED
- Device Name
- Image Processing System EUDAMED
- Model / Reference
- MTS800A EUDAMEDIPS710A EUDAMEDIPS1001A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810000890316 EUDAMED00810000890286 EUDAMED00810000890309 EUDAMED
- Basic UDI-DI
- 081000089031XY EUDAMED081000089028YB EUDAMED081000089030XW EUDAMED
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMEDZ119014 VIDEO RECORDERS FOR BIOIMAGES 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 | 081000089031XY | 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 (3)
- EUDAMED bbbe09a4-b509-4e85-bf1f-f945121f9ac4 61 fields · synced Jul 29, 2026
- EUDAMED e8775aee-2e03-4ed3-80e5-18916f289d74 61 fields · synced May 17, 2026
- EUDAMED 700a24df-2182-426f-9a36-5b6923e2f873 61 fields · synced May 19, 2026