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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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The wellbeing services county of Southwest Finland

Certificate CR-03-1220-858-24

Rev. 02Supplemented
Valid until
Nov 25, 2029

Overview

Certificate number
CR-03-1220-858-24
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
0537CR-03-1220-858-2402

Validity

Issued
Mar 25, 2026
Valid from
Mar 25, 2026
Valid until
Nov 25, 2029

Manufacturer

Manufacturer
The wellbeing services county of Southwest Finland
Manufacturer SRN
FI-MF-000038025
Manufacturer country
Finland

Notified body

Notified body
Eurofins Electric & Electronics Finland Oy
Notified body SRN
0537
Notified body country
Finland

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

History

Status changes

  • Supplemented

Supersedes

  • CR-03-1220-858-24Quality management systemIssuedNov 25, 2024 → Nov 25, 2029

Scope coverage

Class IIb2

2 scopes

  • MDA 0315 Software
    Class IIb
  • CarimasCE (v1.4)
    Class IIb

Documents

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