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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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SACIMEX

Certificate 2026 PR 0068

Rev. 2Issued
Valid until
Jan 13, 2031

Overview

Certificate number
2026 PR 0068
Certificate type
Quality assurance
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
03182026 PR 00682

Validity

Issued
Feb 5, 2026
Valid from
Feb 5, 2026
Valid until
Jan 13, 2031

Notified body

Notified body
CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS
Notified body SRN
0318
Notified body country
Spain

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I19

19 scopes

  • MDN 1208: Instrumentos no activos y no implantables / Non-active non-implantable instruments
    Class I
  • Soporte de microcaja/ Micro cage holder
    Class I
  • Soporte de impactador de microcaja / Micro cage impactor holder
    Class I
  • Guía recuperadora de trasplante / Transplant pulling guide
    Class I
  • Guía de broca / Drill guide
    Class I
  • Tapón / Cap
    Class I
  • Guía para tornillo de la caja / Screw cage Guide
    Class I
  • Destornillador para caja de fijación tibial/ Tibial fixation cage screwdriver
    Class I
  • Destornillador para tornillo de caja de fijación/ Fixation cage screw screwdriver
    Class I
  • Destornillador para caja de fijación femoral/ Femoral fixation cage screwdriver
    Class I
  • Macho de rosca Ø 8 mm L 15mm / Ø 8mm L 15mm Tap
    Class I
  • Macho de rosca DT4-EBCA Ø 8 mm L 12mm / Ø 8mm L 12mm DT4-EBCA Tap
    Class I
  • Guía de alambre DT4 / DT4 wire pusher
    Class I
  • Visor tibial/ Tibial guide
    Class I
  • Visor femoral/ Femoral guide
    Class I
  • Visor con desplazamiento femoral de 5 mm/ 5mm femoral offset guide
    Class I
  • Visor con desplazamiento femoral de 6 mm/ 6mm femoral offset guide
    Class I
  • Indicador de profundidad / Depth indicator
    Class I
  • Calibrador de trasplante / Transplant calibrator
    Class I

Documents

LanguagesENES

Manufacturer

Manufacturer
SACIMEX
Manufacturer SRN
FR-MF-000011190
Manufacturer country
France