Scitech Produtos Médicos SA

Certificate 2025-MDR/TD-015

Rev. 00Issued

Valid until: Feb 7, 2030

Certificate 2025-MDR/TD-015 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-015
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/TD-01500

Validity

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

Manufacturer

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

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Vascular Stent GraftClass IIb
79082497SOLARISCB

Linked SSCPs

SSCP CE019 - SSCP - Solaris

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

Vascular Stent Graft
Class IIb
79082497SOLARISCB

Documents

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