Tracey Technologies

Certificate US25/00000029

Rev. 4Amended

Valid until: Jan 21, 2030

Certificate US25/00000029 is a valid Quality management system issued to Tracey Technologies and registered in EUDAMED. Valid until January 21, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: US25/00000029
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 1639US25/000000294

Validity

Issued: Feb 24, 2026
Valid from: Feb 24, 2026
Valid until: Jan 21, 2030

Manufacturer

Manufacturer: Tracey Technologies
Manufacturer SRN: US-MF-000027372
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Status changes

Amended

Supersedes

US25/00000029Quality management systemAmendedDec 4, 2025 → Jan 21, 2030

Scope coverage

Class IIa2

2 scopes

MDA0202, MDS1009, MDS1010
Class IIa
Tracey VFA Visual Function Analyser
Class IIa

Documents

LanguagesEN