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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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CLOUDS OF CARE NV

Certificate BE24/00000249

Rev. 2Issued
Valid until
Sep 24, 2029

Overview

Certificate number
BE24/00000249
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1639BE24/000002492

Validity

Issued
Aug 19, 2025
Valid from
Aug 19, 2025
Valid until
Sep 24, 2029

Manufacturer

Manufacturer
CLOUDS OF CARE NV
Manufacturer SRN
BE-MF-000003302
Manufacturer country
Belgium

Notified body

Notified body
SGS Belgium NV
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
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

  • MDA0315, MDS1009
    Class IIa
  • Persyst ESI powered by Epilog, V3: Software for the visualization of epileptic activity
    Class IIa

Documents

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