Identity
- Trade Name
- WUH4000 EUDAMED
- Device Name
- Wireless Imaging System EUDAMED
- Model / Reference
- WUH4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810000890545 EUDAMED
- Basic UDI-DI
- 081000089054YC 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
Wuh4000 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 | 081000089054YC | 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 453013e4-bd50-4421-9638-2b651f06e1e6 61 fields · synced Jun 18, 2026