Identity
- Trade Name
- MTS101 EUDAMEDMTS FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- Monitor with Touch Screen EUDAMEDThis touchscreen monitor is used for external operation of devices with a graphical user interface. Power is supplied via USB of the host device. Supply of graphic information (video signal) is via HDMI or DVI. The MTS has no operating elements. The start-up takes place automatically as soon as the supply voltage and the video signal are present and recognized.This device is intended as user interface (human-machine interface) for various medical devices. It is not intended for diagnostic purposes. FDA UDI
- Model / Reference
- MTS101 EUDAMEDFDA UDI
- Description
- This touchscreen monitor is used for external operation of devices with a graphical user interface. Power is supplied via USB of the host device. Supply of graphic information (video signal) is via HDMI or DVI. The MTS has no operating elements. The start-up takes place automatically as soon as the supply voltage and the video signal are present and recognized.This device is intended as user interface (human-machine interface) for various medical devices. It is not intended for diagnostic purposes. FDA UDI
Identifiers
- Catalog Number
- MTS101 FDA UDI
- Primary DI / UDI-DI
- 00859151005286 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859151005MTS10144 EUDAMED
- FDA Product Code
- FWB FDA UDI
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
- GMDN Term
- Image display unit, colour FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mts101 by Medicapture, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0859151005MTS10144 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MediCapture, Inc.
- EUDAMED SRN
- US-MF-000013680
- Authorised Representative
- MEDICAPTURE EUROPE B.V. NL-AR-000018862
Sources (2)
- EUDAMED 0f6da805-bd25-4d48-bdc6-74af7257381f 61 fields · synced Jun 17, 2026
- FDA UDI 8e6b37c3-ee14-4672-9501-28c352e50a27 35 fields · synced May 25, 2026