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Biosoft

by Biopsybell SRL 63 variants

Ref BSF1707C

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn 15 Jun 2026

CE MDR

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BUREAU VERITAS ITALIA S.P.A.

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European UnionCE/MDR NumberIT349638 Date10 Feb 2026IssuedStatusWithdrawn expires 9 Feb 2030 withdrawn 15 Jun 2026

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Needles for Biopsy or Explant
Model / Reference
BSF1707C
Primary DI / UDI-DI
08033860026806
Basic UDI-DI
8033860BIOEFT01U5
EMDN Code
A0102010102 Shearing biopsy guns
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000011601

Other devices from Biopsybell SRL

See all devices from Biopsybell SRL →

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