Identity
- Trade Name
- Tablet PC with Enclosure EUDAMED
- Device Name
- Tablet PC with Enclosure EUDAMED
- Model / Reference
- WIS4100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810000890675 EUDAMED
- Basic UDI-DI
- 081000089067YM EUDAMED
- EMDN Code
- Y210999 PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER 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
Tablet PC with Enclosure 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 | 081000089067YM | 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 30f9c241-6f90-47d0-bad1-a508d2e1b4bc 61 fields · synced Jun 18, 2026