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BioMin F Sensitivity 18ml

by BioMin Technologies Ltd

Ref FGTB004

Active European Union

CE MDR

Valid until

7 Oct 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier National Standards Authority of Ireland (NSAI)

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 Number745.181 Date8 Oct 2026IssuedStatusActive expires 7 Oct 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 745.181 Active

    Quality management system EU MDR

    Certifier
    National Standards Authority of Ireland (NSAI) 0050
    Issued
    8 Oct 2026
    Expires
    7 Oct 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
BioMin F Sensitivity
Model / Reference
FGTB004
Primary DI / UDI-DI
05070002922339
Basic UDI-DI
50700029223BioMinFRL
EMDN Code
Q019008 Dentinal desensitisers
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000007128
Authorised representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

From the manufacturer

Manufacturer's product page: BioMin F

Other devices from BioMin Technologies Ltd

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