Instrumentation Laboratory SpA

Certificate V12 034483 0002

Rev. Rev. 01Issued

Valid until: Oct 2, 2027

Certificate V12 034483 0002 is a valid Quality management system issued to Instrumentation Laboratory SpA and registered in EUDAMED. Valid until October 2, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: V12 034483 0002
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: 0123V12 034483 0002Rev. 01

Validity

Issued: Jul 26, 2024
Valid from: Jul 26, 2024
Valid until: Oct 2, 2027

Manufacturer

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
Manufacturer country: Italy

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: No
Human tissues: Yes
Animal tissues: Yes
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 B2

2 scopes

W0101 - CLINICAL CHEMISTRY
IVDR Class B
W0102 - IMMUNOCHEMISTRY (IMMUNOLOGY)
IVDR Class B

Documents

LanguagesEN