SSI Diagnostica A/S

Certificate V13 133113 0001

Rev. Rev. 00Issued

Valid until: Jul 7, 2031

Certificate V13 133113 0001 is a valid Quality management system issued to SSI Diagnostica A/S and registered in EUDAMED. Valid until July 7, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: V13 133113 0001
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: 0123V13 133113 0001Rev. 00

Validity

Issued: Jul 8, 2026
Valid from: Jul 8, 2026
Valid until: Jul 7, 2031

Manufacturer

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
Manufacturer country: Denmark

Notified body

Notified body
Notified body SRN: 0123
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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C1

1 scope

W0105 + IVP 3007 - Infectious diseases
IVDR Class C

Documents

LanguagesEN