Identity
- Trade Name
- MTS156 EUDAMEDMTS FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- Monitor with Touch Screen EUDAMEDFDA UDI
- Model / Reference
- MTS101 EUDAMEDMTS156 EUDAMEDFDA UDI
- Description
- Monitor with Touch Screen FDA UDI
Identifiers
- Catalog Number
- MTS156 FDA UDI
- Primary DI / UDI-DI
- 00859151005057 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859151005MTS10144 EUDAMED
- FDA Product Code
- FWH 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
Mts156 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 e4997775-a3f4-4428-9ab1-e481e4bcd30e 61 fields · synced Jun 17, 2026
- FDA UDI d6a3ac5e-40c6-485a-97d1-986320af1f7d 36 fields · synced May 30, 2026