SPD Swiss Precision Diagnostics GmbH

Certificate V74 099371 0022

Rev. Rev. 01Supplemented

Valid until: Feb 25, 2030

Certificate V74 099371 0022 is a valid Technical documentation issued to SPD Swiss Precision Diagnostics GmbH and registered in EUDAMED. Valid until February 25, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: V74 099371 0022
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V74 099371 0022Rev. 01

Validity

Issued: Mar 12, 2026
Valid from: Mar 12, 2026
Valid until: Feb 25, 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 & Weeks Indicator PGTs, Ultra Early & Weeks Indicator PGTs CP, Early Detection & Weeks Indicator PGTs, Early Detection & Weeks Indicator PGTs CP, Test & Confirm PGTs, Test & Conform PGTs CPIVDR Class B
4084500CB14/CB9TL

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

Status changes

Supplemented

Supersedes

V74 099371 0022IssuedFeb 26, 2025 → Feb 25, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class B1

1 scope

Ultra Early & Weeks Indicator PGTs, Ultra Early & Weeks Indicator PGTs CP, Early Detection & Weeks Indicator PGTs, Early Detection & Weeks Indicator PGTs CP, Test & Confirm PGTs, Test & Conform PGTs CP
IVDR Class B
4084500CB14/CB9TL

Documents

LanguagesEN