Skip to content

MRE Phantom Kit

by Resoundant

Ref REMREP15

MRE Phantom Kit (REMREP15) is a Class I device made by Resoundant, registered in EUDAMED on 16 Jul 2024 (Basic UDI-DI B-00850011790069), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00850011790069 Basic UDI-DI 00850011790069UDI-DIDate16 Jul 2024RegisteredStatusActive
European UnionCE/MDD NumberB-00850011790069 Basic UDI-DI 00850011790069UDI-DIDate16 Jul 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade name
MRE Phantom Kit
Resoundant MRE phantom kit
Model / reference
REMREP15
Primary DI / UDI-DI
00850011790069
Basic UDI-DI
B-00850011790069, 0850011790REMREP15MD
EMDN code
Z11059080, Z11059099
Device class
Class I
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany

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

Other properties (14, all answered No)