manufacturing of medical devices

​Fluisense designs, develops and manufactures our own wearable devices for serial blood sampling.

Fluisense also offers Contract Manufacturing in compliance with EN ISO 13485:2016.​

Class 8 clean-room for:

  • Manufacturing of small batches of sterile medical devices
  • Silicone molding
  • Prototype products for clinical investigations
  • Assembly and primary packaging for sterilization
  • To get up and running fast

ESD Assembly area

  • ESD protected assembly of electronic medical devices

​Fluisense currently has manufacturing capability to spare.

We currently manufacture in accordance with theSE standards:

EN ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for regulatory purposes

EN ISO 14971:2019 Risk Management for Medical Devices

EN ISO 10555-1:2013/A1 2017 Sterile, single-use intravascular catheters

EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices

EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices

EN ISO 14644-1:2015 Cleanrooms and associated controlled environments

EN ISO 14698-1 and -2 - Cleanrooms and associated controlled environments -  Biocontamination Control.

Contact us to learn how we might help you.


New publication on cortisol measurements in Beagle dogs​

​New results just published show that when blood samples are collected in a completely stress-free way, blood cortisol levels in dogs are significantly lower.


Fluisense completes iso 13485:2016 certification

Fluisense is certified for Design, Development, Manufacturing and distribution.
​Fluisense has a certified Class 8 clean-room for contract manufacturing of sterile medical devices.


​Clinical investigation initiated

Fluisense has initiated the healthy volunteer study at DanTrials.


PATENT update

Fluisense has been granted patent in the US. ​


COmpany info

Fluisense ApS

CVR/VAT/EORI: DK32780571

Office hours: Mon - Fri 8 am - 4 pm CET

Closing days


Gydevang 20A

DK-3450 Allerød



Phone: +45 25 94 05 95