SPD Swiss Precision Diagnostics GmbH

Certificate V76 099371 0031

Rev. Rev. 00Issued

Valid until: Nov 3, 2030

Certificate V76 099371 0031 is a valid Technical documentation issued to SPD Swiss Precision Diagnostics GmbH and registered in EUDAMED. Valid until November 3, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: V76 099371 0031
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V76 099371 0031Rev. 00

Validity

Issued: Nov 4, 2025
Valid from: Nov 4, 2025
Valid until: Nov 3, 2030

Manufacturer

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
Manufacturer country: Switzerland

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

Ultra Early & Rapid Pregnancy Tests, Ultra Early & Rapid Pregnancy Tests Combo Pack, Early Detection & Rapid Pregnancy Tests, Early Detection & Rapid Pregnancy Tests Combo PackIVDR Class B
4084500CB11/CB14Q8

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B1

1 scope

Ultra Early & Rapid Pregnancy Tests, Ultra Early & Rapid Pregnancy Tests Combo Pack, Early Detection & Rapid Pregnancy Tests, Early Detection & Rapid Pregnancy Tests Combo Pack
IVDR Class B
4084500CB11/CB14Q8

Documents

LanguagesEN