Copan Italia S.P.A.

Certificate V11 073936 0015

Rev. Rev. 00Issued

Valid until: Apr 18, 2027

Certificate V11 073936 0015 is a valid Quality management system issued to Copan Italia S.P.A. and registered in EUDAMED. Valid until April 18, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: V11 073936 0015
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: 0123V11 073936 0015Rev. 00

Validity

Issued: Apr 19, 2022
Valid from: Apr 19, 2022
Valid until: Apr 18, 2027

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
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 A1

1 scope

W0503 - DEVICES FOR SAMPLES ANALYSES (no laboratory generic products)
IVDR Class A

Documents

LanguagesEN