Diagnostics for the Real World Ltd

Certificate ITDA/00003/0 v002

Rev. v002Amended

Valid until: Nov 3, 2030

Certificate ITDA/00003/0 v002 is a valid Technical documentation issued to Diagnostics for the Real World Ltd and registered in EUDAMED. Valid until November 3, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: ITDA/00003/0 v002
Certificate type: Technical documentation
Certificate status: Amended
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 2
Certificate ID: 2962ITDA/00003/0 v002v002

Validity

Issued: Nov 18, 2025
Valid from: Nov 18, 2025
Valid until: Nov 3, 2030

Manufacturer

Manufacturer: Diagnostics for the Real World Ltd
Manufacturer SRN: US-MF-000023951
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2962
Notified body country: Austria

Covered devices

SAMBA III SCoV-2/Flu/RSV TestIVDR Class B
++B7149000122R

Characteristics

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

History

Status changes

Amended

Supersedes

ITDA/00003/0 v001Technical documentationIssuedNov 4, 2025 → Nov 3, 2030

Scope coverage

IVDR Class B1

1 scope

SAMBA III SCoV-2/Flu/RSV Test
IVDR Class B
++B7149000122R

Documents

LanguagesEN