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Resoundant Passive Driver, Rigid

by Resoundant

Ref REPD2000

Resoundant Passive Driver, Rigid (REPD2000) is a device classified as Class I in the EU and Class II in the US made by Resoundant, registered in EUDAMED on 15 May 2024 (Basic UDI-DI 0850011790REPD20008L), cleared under FDA 510(k) K201389 on 10 Jul 2020 and listed in FDA GUDID since 21 Feb 2023 (UDI-DI 00850011790106), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201389

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850011790REPD20008L Basic UDI-DI 00850011790106UDI-DIDate15 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00850011790106 UDI-DI Date21 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201389 Date10 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0850011790REPD20008L registered 15 May 2024 Active
  • FDA 510(k) K201389 decided 10 Jul 2020 Active
  • FDA GUDID UDI-DI 00850011790106 listed 21 Feb 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201389
  2. Listed FDA GUDID 00850011790106
  3. Registered EUDAMED 0850011790REPD20008L

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Resoundant Passive Driver, Rigid EUDAMED
Passive Driver GUDID
Generic name
Magnetic resonance elastography acoustic driver
Device name
Passive Driver, Rigid
Model / reference
REPD2000
Primary DI / UDI-DI
00850011790106
Basic UDI-DI
0850011790REPD20008L
510(k) Number
FDA product code
LNH
EMDN code
Z11059080 Various magnetic resonance imaging instruments - hardware accessories
GMDN term
Magnetic resonance elastography acoustic driver
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1000
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000037180
Authorised representative
VISAMED GmbH DE-AR-000006285

Similar devices in this category

Other devices filed under VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Resoundant

See all devices from Resoundant →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)