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BoneMRI

by MRIguidance B.V. 7 variants

Ref v1.8

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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233030↗

+1 more

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 Number87193269751BMRI-CNF Basic UDI-DI 08719326975184UDI-DIDate19 Apr 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK233030 Date1 Mar 2024IssuedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
v1.8
Primary DI / UDI-DI
08719326975184
Basic UDI-DI
87193269751BMRI-CNF
Direct Marketing DI
08719326975184
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002682

Other devices from Mriguidance B.V.

  • BoneMRI

    Class II

  • BoneMRI v1.6

    Class II

  • BoneMRI

    Class IIa

  • BoneMRI

    Class IIa

  • BoneMRI

    Class IIa

  • BoneMRI

    Class IIa

See all devices from Mriguidance B.V. →

Properties

Other properties (13)

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