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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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Comerge AG

Certificate ITH 2426703 1

Supplemented
Valid until
Jul 23, 2028

Overview

Certificate number
ITH 2426703 1
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
1936ITH 2426703 1

Validity

Issued
Jul 24, 2023
Valid from
Jul 24, 2023
Valid until
Jul 23, 2028

Manufacturer

Manufacturer
Comerge AG
Manufacturer SRN
CH-MF-000029069
Manufacturer country
Switzerland

Notified body

Notified body
TUV Rheinland Italia SRL
Notified body SRN
1936
Notified body country
Italy

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
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
Yes
MOS outside EUDAMED
—
QMS/MOS type
Others

History

Status changes

  • Supplemented

Supersedes

  • ITH 2426703 1Quality management systemIssuedJul 24, 2023 → Jul 23, 2028

Scope coverage

Class I1

1 scope

  • Software
    Class I

Documents

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