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MEDRAD® MRXperion MR Injection System Syringe Kit

by Bayer Medical Care Inc.

Ref XP 115VS

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143538↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0090QH Basic UDI-DI Date5 Feb 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK143538 Date14 Aug 2015IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2244-2016 FDA Class II initiated 9 Jun 2016 on shared 510(k) K143538

    Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
XP 115VS
Primary DI / UDI-DI
00616258022253, 00616258024974
Basic UDI-DI
0616258TFCN-0090QH
EMDN Code
A02010401 Syringes for contrast media injector, single-use
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

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Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No