MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

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

Subscribe to our monthly newsletter:

  • MD Atlas
  • Documents

SIS Medical AG

Certificate 44912221715

Rev. 2Amended
Valid until
Feb 27, 2030

Certificate 44912221715 is a valid Technical documentation issued to SIS Medical AG and registered in EUDAMED. Valid until February 27, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
44912221715
Certificate type
Technical documentation
Certificate status
Amended
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
0044449122217152

Validity

Issued
May 6, 2026
Valid from
May 6, 2026
Valid until
Feb 27, 2030

Manufacturer

Manufacturer
SIS Medical AG
Manufacturer SRN
CH-MF-000015821
Manufacturer country
Switzerland

Notified body

Notified body
TÜV NORD CERT GmbH
Notified body SRN
0044
Notified body country
Germany

Characteristics

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

History

Status changes

  • Amended

Supersedes

  • 44912221715Technical documentationIssuedFeb 28, 2025 → Feb 27, 2030

Scope coverage

Unspecified2

2 scopes

  • EasyT
    764014257NIC_ETEM
  • OPN NC
    764014257OPN_NCKM

Documents

LanguagesEN

Covered devices

  • EasyTClass III
    764014257NIC_ETEM
  • OPN NCClass III
    764014257OPN_NCKM