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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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MD Atlas
Documents

Diaverum AB

Certificate 28620245967

Rev. 00Issued

Valid until: Apr 19, 2031

Overview

Certificate number: 28620245967
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862024596700

Validity

Issued: May 19, 2026
Valid from: May 19, 2026
Valid until: Apr 19, 2031

Manufacturer

Manufacturer: Diaverum AB
Manufacturer SRN: SE-MF-000050680
Manufacturer country: Sweden

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Web application for the management of patients in need of renal care, or care for associated comorbidities.
Class IIb
d.CARE Platform
Class IIb

Documents

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