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MVR435

by MediCapture, Inc.

Part of a family of 7 devices: see the family page

Ref MVR435

MVR435 is a Class I device made by Medicapture, Inc., registered in EUDAMED on 8 Jan 2025 (Basic UDI-DI 0859151005MVR8K) and listed in FDA GUDID since 27 Jan 2025 (UDI-DI 00859151005064), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00859151005064 UDI-DI Date27 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0859151005MVR8K Basic UDI-DI 00859151005064UDI-DIDate8 Jan 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0859151005MVR8K registered 8 Jan 2025 Active
  • FDA GUDID UDI-DI 00859151005064 listed 27 Jan 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0859151005MVR8K
  2. Listed FDA GUDID 00859151005064

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  • Withdrawn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
MVR435 EUDAMED
Mvr GUDID
Generic name
Medical video image recorder
Model / Ref / Catalog
MVR435
Primary DI / UDI-DI
00859151005064
Basic UDI-DI
0859151005MVR8K
FDA product code
LMD
EMDN code
Z119014 Video recorders for bioimages
GMDN term
Medical video image recorder
Device class
Class I
Regulation number
892.2020
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 BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

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)