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ICSI Dish

by BIRR Biosciences BV 2 variants

Ref 1130-ICSIModel TD03

Active European Union

CE MDR

Valid until

21 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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 NumberBE25/00000073 Date25 Jun 2026IssuedStatusActive expires 21 Mar 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE25/00000073 Restricted

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    25 Jun 2026
    Expires
    21 Mar 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ART Dish
Model / Reference
TD03, 1130-ICSI
Primary DI / UDI-DI
08717973713494
Basic UDI-DI
87179737103YQ
Direct Marketing DI
08717973713494
EMDN Code
U080206 Culture plates for assisted reproduction
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
NL-MF-000023194

Other devices from BIRR Biosciences BV

See all devices from BIRR Biosciences BV →

Properties

  • Sterile

Other properties (12)

  • 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