Spinreact S.A.U.

Certificate HX 1552211-1

Rev. Rev.0Issued

Valid until: Feb 4, 2030

Certificate HX 1552211-1 is a valid Quality management system issued to Spinreact S.A.U. and registered in EUDAMED. Valid until February 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1552211-1
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 1552211-1Rev.0

Validity

Issued: Feb 5, 2025
Valid from: Feb 5, 2025
Valid until: Feb 4, 2030

Manufacturer

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
Manufacturer country: Spain

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 B1IVDR Class C1

2 scopes

IVR 0506 Other devices intended to be used to determine markers of infections/immune status W01021105 - ANTI-STREPTOLYSIN O REACTION TIME /TITRE (QUALITATIVE) W01021109 - C-REACTIVE PROTEIN W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
IVDR Class B
IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050103 - SYPHILIS (TREPONEMA PALLIDUM)
IVDR Class C

Documents

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