Attomol GmbH

Certificate HX 1939197-1

Rev. Rev. 0Issued

Valid until: May 2, 2029

Certificate HX 1939197-1 is a valid Quality management system issued to Attomol GmbH and registered in EUDAMED. Valid until May 2, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1939197-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 1939197-1Rev. 0

Validity

Issued: May 3, 2024
Valid from: May 3, 2024
Valid until: May 2, 2029

Manufacturer

Manufacturer: Attomol GmbH
Manufacturer SRN: DE-MF-000026028
Manufacturer country: Germany

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: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C1

1 scope

GENETIC TESTING IVR 0402: Devices intended to be used to predict genetic disease/disorder risk and prognosis W01060101 - MONOGENETIC DISORDERS W01060102 - POLYGENETIC DISORDERS W01060104 - POLYMORPHISMS W010699 - GENETIC TESTS - OTHER
IVDR Class C

Documents

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