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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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Bittium Biosignals Oy

Certificate CR-03-1030-811-22

Rev. 04Supplemented
Valid until
Jun 22, 2027

Overview

Certificate number
CR-03-1030-811-22
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
6
Certificate ID
0537CR-03-1030-811-2204

Validity

Issued
Nov 3, 2025
Valid from
Nov 3, 2025
Valid until
Jun 22, 2027

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
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
No
QMS/MOS type
Others

History

Status changes

  • Supplemented

Supersedes

  • CR-03-1030-811-22Quality management systemSupplementedMar 10, 2025 → Jun 22, 2027

Scope coverage

Class IIa8

8 scopes

  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
    Class IIa
  • MDA 0315 Software
    Class IIa
  • MedicalSuite Mobile (v3.x)
    Class IIa
  • MedicalSuite Center (v3.x)
    Class IIa
  • Bittium Respiro
    Class IIa
  • Bittium APV20
    Class IIa
  • Bittium Respiro Analyst (v2.x)
    Class IIa
  • Bittium Mini UL
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Bittium Biosignals Oy
Manufacturer SRN
FI-MF-000013983
Manufacturer country
Finland