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3018

Sertio Oy

🇫🇮 Finland · Tampere Active

www.sertio.fi

Designations

IVDR In vitro diagnostic medical devices · Regulation (EU) 2017/746 Active
Conformity assessment annexesAnnex IX(I), Annex IX(II), Annex XI
Designated since2023-10-31
IVR 0301Devices intended to be used in screening, diagnosis, staging or monitoring of cancer IVR 0302Other devices intended to be used for markers of cancer and non-malignant tumours IVR 0401Devices intended to be used in screening/confirmation of congenital/inherited disorders IVR 0402Devices intended to be used to predict genetic disease/disorder risk and prognosis IVR 0403Other devices intended to be used for human genetic testing IVR 0501Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents IVR 0502Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration IVR 0503Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents IVR 0504Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging IVR 0505Devices intended to be used to grow/isolate/identify and handle infectious agents IVR 0506Other devices intended to be used to determine markers of infections/immune status IVR 0601Devices intended to be used for screening/confirmation of specific disorders/impairments IVR 0602Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease IVR 0603Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances IVR 0604Other devices intended to be used for a specific disease IVR 0605Devices intended to be used for monitoring of levels of medicinal products, substances or biological components IVR 0606Devices intended to be used for non-infectious disease staging IVR 0607Devices intended to be used for detection of pregnancy or fertility testing IVR 0608Devices intended to be used for screening, determination or monitoring of physiological markers IVR 0609Other devices intended to be used to define or monitor physiological status and therapeutic measures IVR 0701Devices which are controls without a quantitative assigned value IVR 0702Devices which are controls without a qualitative assigned value IVR 0801Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746 IVR 0802Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746 IVR 0803Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
Full scope text from the register
Annexes
  • Annex IX(I), Annex IX(II), Annex XI
Procedures
  • Conformity assessment based on assessment of technical documentation, Conformity assessment based on a quality management system, Conformity assessment based on product quality assurance
Products
  • IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
  • 4. Devices intended to be used for human genetic testing
  • IVR 0403 Other devices intended to be used for human genetic testing
  • IVR 0506 Other devices intended to be used to determine markers of infections/immune status
  • IVR 0604 Other devices intended to be used for a specific disease
  • IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging
  • IVR 0606 Devices intended to be used for non-infectious disease staging
  • 6. Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures
  • IVR 0701 Devices which are controls without a quantitative assigned value
  • 8. Class A devices in sterile condition
  • 7. Devices which are controls without a quantitative or qualitative assigned value
  • IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
  • IVR 0702 Devices which are controls without a qualitative assigned value
  • IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures
  • 5. Devices intended to be used to determine markers of infections/immune status
  • IVR 0502 Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration
  • IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
  • IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders
  • IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances
  • IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
  • IVR 0501 Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents
  • 3. Devices intended to be used for markers of cancer and non-malignant tumours
  • IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease
  • IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing
  • IVR 0802 Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
  • IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
  • IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
  • IVR 0601 Devices intended to be used for screening/confirmation of specific disorders/impairments
  • IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours
  • IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
  • I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
  • IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=3018

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.