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Self Therapy Enbios

by Bio Brem SA Switzerland EUDAMED

Ref STENB01Model Self Therapy

EMDN Z120606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7649989552Self_TherapyMB Basic UDI-DIDate17 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030113-00 Suspended

    Quality assurance EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    20 Dec 2024
    Expires
    19 Dec 2029
    Reason
    Failure contractual obligations

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Self Therapy, STENB01
Primary DI / UDI-DI
07649989552037
Basic UDI-DI
7649989552Self_TherapyMB
Direct Marketing DI
07649989552037
EMDN Code
Z120606 Magnetotherapy equipment
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000042028
Authorised representative
Azienda Tecnica S.r.l. IT-AR-000039329

Other devices from Bio Brem SA

  • Self Therapy

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 3109a29f-b99b-44cf-8278-d81ac6e1a33d 61 fields · synced 22 Oct 2026