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Butterfly prostatic retraction device size XL

by Butterfly Medical Ltd. EUDAMED

Active European Union

Ref BM1116Model Butterfly Prostatic Retraction Device

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290017685ButterflyPRD1AT Basic UDI-DIDate9 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1408700010 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0483
    Issued
    29 Apr 2026
    Expires
    28 Apr 2031

Specification

EUDAMED

Model / Reference
Butterfly Prostatic Retraction Device, BM1116
Primary DI / UDI-DI
07290017685168
Basic UDI-DI
7290017685ButterflyPRD1AT
EMDN Code
U03010201 Urethral dilators
Device Class
Class IIb
Market of Registration
Lithuania

Manufacturer details

EUDAMED SRN
IL-MF-000021414
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from Butterfly Medical Ltd.

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