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Franke Medical Oy

Finland FI-MF-000015890 Last updated 21 Oct 2026

Devices
4
Registries
EUDAMED
FDA recalls
0

Catalogue4

  • Deko Ref Deko 2000

    Class IIa EUDAMED Active

  • Deko Ref Deko 190

    Class IIa EUDAMED Active

  • Deko Ref Deko 32

    Class IIa EUDAMED Active

  • Deko Ref Deko 25

    Class IIa EUDAMED Active

What Franke Medical Oy makes

Franke Medical Oy manufactures the Deko series of medical devices, which appear to be a line of reusable surgical drapes or sterile barrier systems designed for use in operating rooms and procedural settings. These products are intended to provide contamination control during surgical and invasive procedures, ensuring a sterile field for healthcare professionals.

The company’s portfolio is classified under EU Medical Device Regulation (MDR) as Class IIa devices, indicating a moderate risk level requiring conformity assessment procedures. These devices are registered in the EU’s eudamed database, adhering to regulatory requirements for traceability and transparency. Franke Medical Oy is based in Finland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Franke Medical Oy manufacture?

Franke Medical Oy specializes in the Deko series, which consists of reusable surgical drapes or sterile barrier systems. These devices are designed for use in operating rooms and procedural settings to maintain a sterile field during surgical and invasive procedures, helping prevent contamination.

Where is Franke Medical Oy based?

Franke Medical Oy is headquartered in Finland, operating as a Finnish manufacturer within the European medical device market.

Which regulatory registries list Franke Medical Oy’s devices?

Franke Medical Oy’s devices are registered in the eudamed database, the EU’s official registry for medical devices. This ensures compliance with EU transparency requirements, allowing healthcare professionals and authorities to verify device details.

How are Franke Medical Oy’s devices classified under EU regulations?

Franke Medical Oy’s Deko series is classified as Class IIa under the EU Medical Device Regulation (MDR). This classification reflects a moderate risk level, requiring specific conformity assessment procedures to ensure safety and performance before market placement.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Finland(from SRN)
Address
1, Vartiokuja, Naarajärvi, Finland
Website
www.frankemedical.com This website did not respond when we last checked — the domain may no longer be active.Last checked 18 Oct 2026.
Phone
+358443411412
PRRC contact
Mikko Heikkinen
EUDAMED SRN
FI-MF-000015890