Skip to content

MTS101

by MediCapture, Inc.

Ref MTS101

MTS101 is a Class I device made by Medicapture, Inc., registered in EUDAMED on 8 Jan 2025 (Basic UDI-DI 0859151005MTS10144) and listed in FDA GUDID since 21 Feb 2023 (UDI-DI 00859151005286), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0859151005MTS10144 Basic UDI-DI 00859151005286UDI-DIDate8 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00859151005286 UDI-DI Date21 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0859151005MTS10144 registered 8 Jan 2025 Active
  • FDA GUDID UDI-DI 00859151005286 listed 21 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00859151005286
  2. Registered EUDAMED 0859151005MTS10144

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
MTS101 EUDAMED
Mts GUDID
Generic name
Image display unit, colour
Device name
Monitor with Touch Screen
Model / Ref / Catalog
MTS101
Primary DI / UDI-DI
00859151005286
Basic UDI-DI
0859151005MTS10144, 0859151005MTS8F
FDA product code
FWB
EMDN code
Z11900802 Bioimaging viewing monitors
GMDN term
Image display unit, colour
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000013680
Authorised representative
MEDICAPTURE EUROPE B.V. NL-AR-000018862

Similar devices in this category

Other devices filed under BIOIMAGING VIEWING MONITORS.

Other devices from Medicapture, Inc.

  • MTR245W

    Class I

  • MTS156W

    Class I

  • MTR133W

    Class I

  • MSP245

    Class I

See all devices from Medicapture, Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)