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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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MD Atlas
Documents

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

LanguagesENIT