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MTR245W

by MediCapture, Inc.

Part of a family of 6 devices: see the family page

Ref MTR245W

MTR245W is a Class I device made by Medicapture, Inc., registered in EUDAMED on 8 Jan 2025 (Basic UDI-DI 0859151005MTR8D) and listed in FDA GUDID since 19 Oct 2026 (UDI-DI 00859151005316), active as of 2 Nov 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00859151005316 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0859151005MTR8D Basic UDI-DI 00859151005316UDI-DIDate8 Jan 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0859151005MTR8D registered 8 Jan 2025 Active
  • FDA GUDID UDI-DI 00859151005316 listed 19 Oct 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0859151005MTR8D
  2. Listed FDA GUDID 00859151005316

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  • Withdrawn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
MTR245W EUDAMED
Mtr GUDID
Generic name
Medical video image recorder
Device name
Touchscreen Video Recorder
Model / reference
MTR245W
Primary DI / UDI-DI
00859151005316
Basic UDI-DI
0859151005MTR8D
FDA product code
FWH
EMDN code
Z11069099 Various digital bioimaging management instruments - other
GMDN term
Medical video image recorder
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 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS.

Other devices from Medicapture, Inc.

  • MTS156W

    Class I

  • MTR133W

    Class I

  • MSP245

    Class I

  • MSP245W

    Class I

See all devices from Medicapture, Inc. →

Properties

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