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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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SICAT GmbH & Co. KG

Certificate HZ 1703016-1

Rev. Rev.2Reissued
Valid until
Jun 25, 2031

Certificate HZ 1703016-1 is a valid Quality management system issued to SICAT GmbH & Co. KG and registered in EUDAMED. Valid until June 25, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number
HZ 1703016-1
Certificate type
Quality management system
Certificate status
Reissued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197HZ 1703016-1Rev.2

Validity

Issued
Apr 28, 2026
Valid from
Jun 26, 2026
Valid until
Jun 25, 2031

Notified body

Notified body
TÜV Rheinland LGA Products GmbH
Notified body SRN
0197
Notified body country
Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Supersedes

  • HZ 1703016-1Quality management systemIssuedJun 9, 2022 → Jun 25, 2026

Scope coverage

Class IIa1

1 scope

  • Z110603 - PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
SICAT GmbH & Co. KG
Manufacturer SRN
DE-MF-000005604
Manufacturer country
Germany