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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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QUANTIQ.IO

Certificate 115371

Rev. 1Issued
Valid until
Feb 19, 2030

Overview

Certificate number
115371
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
03331153711

Validity

Issued
Oct 22, 2025
Valid from
Oct 22, 2025
Valid until
Feb 19, 2030

Manufacturer

Manufacturer
QUANTIQ.IO
Manufacturer SRN
FR-MF-000024003
Manufacturer country
France

Notified body

Notified body
AFNOR Certification
Notified body SRN
0333
Notified body country
France

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
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

  • Software that measures the pulse and respiratory rates using a camera (MDA 0315)
    Class IIa
  • COBOX V1
    Class IIa

Documents

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