On 21 October 2025, SGS FIMKO OY was added to the NANDO database as a notified body for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
With this new designation, the number of notified bodies recognised under the IVDR has now reached 19.
SGS FIMKO OY
Takomotie 8
00380 Helsinki
Finland
+358 9 696 361
nb.fimko@sgs.com
www.sgs.fi
Body number: 0598
The Notification covers the following:
Devices intended to be used for markers of cancer and non-malignant tumours
- IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
- IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours
Devices intended to be used for human genetic testing
- IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders
- IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
- IVR 0403 Other devices intended to be used for human genetic testing
Devices intended to be used to determine markers of infections/immune status
- IVR 0501 Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents
- 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 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
- 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 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
- IVR 0506 Other devices intended to be used to determine markers of infections/immune status
Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures
- IVR 0601 Devices intended to be used for screening/confirmation of specific disorders/impairments
- IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease
- IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances
- IVR 0604 Other devices intended to be used for a specific disease
- IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
- IVR 0606 Devices intended to be used for noninfectious disease staging
- IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing
- IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
- IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures
Devices which are controls without a quantitative or qualitative assigned value
- IVR 0701 Devices which are controls without a quantitative assigned value
- IVR 0702 Devices which are controls without a qualitative assigned value
Class A devices in sterile condition
- IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
- 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 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
You can find the full scope of its designation on the following link.
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