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Guia De Brocado De Grapas Mango Metalico Y Tubos Intercambiables

by Ivalmed S.L.

Ref IV792-91-10

Active European Union

CE MDR

Valid until

30 Mar 2031

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 22 Oct 2026. What this means

Overview

This GUIA DE BROCADO DE GRAPAS MANGO METALICO Y TUBOS INTERCAMBIABLES is a medical device designed for the treatment of diabetes, utilizing a unique metal-ceramic technology. Its endocrine disruptor properties and reprocessor status indicate that it should not be used in clinical settings without proper medical evaluation.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberES26/00000408 Date30 Mar 2026IssuedStatusActive expires 30 Mar 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • ES26/00000408 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    30 Mar 2026
    Expires
    30 Mar 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Instrumentos De Guia
Model / Reference
IV792-91-10
Primary DI / UDI-DI
08435760840191
Basic UDI-DI
84357608INSGUIA5K
Direct Marketing DI
08435760840191
EMDN Code
L0399 General surgery instruments, reusable - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000634

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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