Identity
- Trade Name
- FHD-1TX-1RX EUDAMED
- Device Name
- Wireless Imaging System EUDAMED
- Model / Reference
- FHD-1TX-1RX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810000890521 EUDAMED
- Basic UDI-DI
- 081000089052Y8 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
Fhd-1tx-1rx 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 | 081000089052Y8 | 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 447e6770-2ce5-4b0c-aca3-67b8c50a0e24 61 fields · synced Jul 15, 2026