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Burr

by CIZETA SURGICAL S.r.l. 97 variants

Ref 0427100-8

Active European Union

CE MDR

Valid until

14 Sep 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ITALCERT SRL

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Overview

The Burr medical device is a Class IIa surgical instrument designed for precise and accurate dissection and suturing. Its sterilization method ensures sterility, making it ideal for use in high-risk environments.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805004697P0180WQ Basic UDI-DI 08050046976069UDI-DIDate23 Oct 2023RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 029-00-00-MDR Active

    Quality management system EU MDR

    Certifier
    ITALCERT SRL 0426
    Issued
    15 Sep 2023
    Expires
    14 Sep 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Burr
Model / Reference
0427100-8
Primary DI / UDI-DI
08050046976069
Basic UDI-DI
805004697P0180WQ
EMDN Code
P0180 Facial and odontological prostheses - accessories
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027906

Other devices from CIZETA SURGICAL S.r.l.

  • Membrane Fixing Pin

    Class IIb

  • Burr

    Class IIa

  • Blockage Pin

    Class IIb

  • Pin Di Fissaggio

    Class IIb

  • Burr

    Class IIa

  • Burr

    Class IIa

See all devices from CIZETA SURGICAL S.r.l. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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