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Digital Documentation Tablet PC
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref WIS4000
Identity
- Trade Name
- Digital Documentation Tablet PC EUDAMEDFSN FDA UDI
- Generic Name
- Portable computer FDA UDI
- Device Name
- Digital Documentation Tablet PC EUDAMEDWireless Imaging System FDA UDI
- Model / Reference
- WIS4000 EUDAMEDFDA UDI
- Description
- Wireless Imaging System FDA UDI
Identifiers
- Catalog Number
- WIS4000 FDA UDI
- Primary DI / UDI-DI
- 00810000890040 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000089004XV EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Y210999 PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Portable computer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Digital Documentation Tablet PC by Foreseeson Custom Displays, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112621 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081000089004XV | 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 af399b0a-24c4-4f37-82c4-0842d75951ef 61 fields · synced Jul 12, 2026
- FDA UDI ce64a434-58c9-4f14-837f-be01f7a5ed70 35 fields · synced May 30, 2026
- FDA 510(k) K112621 1 fields · synced May 18, 2026