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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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Pedihealth Oy

Certificate FI25/00000046

Rev. Issue 1Issued
Valid until
Jul 29, 2030

Certificate FI25/00000046 is a valid Quality management system issued to Pedihealth Oy and registered in EUDAMED. Valid until July 29, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
FI25/00000046
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0598FI25/00000046Issue 1

Validity

Issued
Jul 30, 2025
Valid from
Jul 30, 2025
Valid until
Jul 29, 2030

Notified body

Notified body
SGS FIMKO OY
Notified body SRN
0598
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
Yes
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
Yes
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I2

2 scopes

  • EMDN V030299 Dimensional clinical parameters measuring devices - other
    Class I
  • Pedi-Scoliometer, product number 30131, Basic UDI-DI 64300715330131G9
    Class I

Documents

LanguagesEN

Manufacturer

Manufacturer
Pedihealth Oy
Manufacturer SRN
FI-MF-000000503
Manufacturer country
Finland