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.​

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 

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.

News

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.

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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.

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​Clinical investigation initiated

Fluisense has initiated the healthy volunteer study at DanTrials.

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PATENT update

Fluisense has been granted patent in the US. ​

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COmpany info

Fluisense ApS

CVR/VAT: DK32780571

EORI: GB086466572000 

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

Closing days

ADdress

Gydevang 20A

DK-3450 Allerød

Denmark

Contact

Phone: +45 25 94 05 95

E-mail: info@fluisense.com

Invoices: accounting@fluisense.com