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Omnium1 Intelligent Wellness

by Swiss Bionic Solutions Schweiz GmbH

Ref 75210Model iMRS prime

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7649998449PEMFT6 Basic UDI-DI 07649998449021UDI-DIDate27 Apr 2023RegisteredStatusWithdrawn

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
iMRS prime SET
Model / Reference
iMRS prime, 75210
Primary DI / UDI-DI
07649998449021
Basic UDI-DI
7649998449PEMFT6
EMDN Code
Z120606 Magnetotherapy equipment
Device Class
Class IIa
Medical Purpose
For the promotion of bone healing, e.g. in case of bone fracture For the reduction of pain sensation, e.g. from musculoskeletal disorders For improved wound healing For improved peripheral microcirculation

Manufacturer details

EUDAMED SRN
CH-PR-000034867

Properties

Other properties (1)

  • Sterile: No