Orla DTx Oy

Certificate FI26/00000015

Rev. Issue 1Issued

Valid until: Feb 5, 2029

Certificate FI26/00000015 is a valid Quality management system issued to Orla DTx Oy and registered in EUDAMED. Valid until February 5, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: FI26/00000015
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI26/00000015Issue 1

Validity

Issued: Feb 6, 2026
Valid from: Feb 6, 2026
Valid until: Feb 5, 2029

Manufacturer

Manufacturer: Orla DTx Oy
Manufacturer SRN: FI-MF-000041810
Manufacturer country: Finland

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

Covered devices

Asthma CalculatorClass IIa
6429811352AC_01ZL

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0315, MDS 1009, MDT 2011  EMDN V92 – Medical device software - not included in other classes
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN