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Scitech Produtos Médicos SA

Certificate 2025-MDR/TD-016

Rev. 00Issued
Valid until
Feb 7, 2030

Certificate 2025-MDR/TD-016 is a valid Technical documentation issued to Scitech Produtos Médicos SA and registered in EUDAMED. Valid until February 7, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
2025-MDR/TD-016
Certificate type
Technical documentation
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
22652025-MDR/TD-01600

Validity

Issued
Feb 7, 2025
Valid from
Feb 7, 2025
Valid until
Feb 7, 2030

Notified body

Notified body
3EC International a.s.
Notified body SRN
2265
Notified body country
Slovakia

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

  • Peripheral Angioplasty Balloon Catheter
    79082497GIANTVD

Documents

LanguagesEN

Manufacturer

Manufacturer
Scitech Produtos Médicos SA
Manufacturer SRN
BR-MF-000018627
Manufacturer country
Brazil

Covered devices

  • Peripheral Angioplasty Balloon CatheterClass III
    79082497GIANTVD

Linked SSCPs

  • SSCP CE019 - SSCP - Giant