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MINIject

by iSTAR Medical S.A 5 variants

Ref FG1004PBModel FG1004

Expired European Union

Was authorized under CE MDR, expired

Ended

Expired 27 Oct 2026

CE MDR

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 732654 Date20 Jul 2026IssuedStatusExpired expired 27 Oct 2026

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 732654 Expired

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    20 Jul 2026
    Expires
    27 Oct 2026
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expired

Specification

EUDAMED

Model / Reference
FG1004, FG1004PB
Primary DI / UDI-DI
05425033253028
Basic UDI-DI
542503325-MINIJECT-627-7B
EMDN Code
Q0208 Glaucoma drainages and kits
Device Class
Class IIb
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
BE-MF-000004821

Other devices from iSTAR Medical S.A

  • MINIject S

    Class IIb

  • MINIject

    Class IIb

  • MINIject S

    Class IIb

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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