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Bioton S.A.

Active in EUDAMED

Polandfrom SRN EUDAMED SRN PL-MF-000030862

Devices
3
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

Catalogue3

Newest first, rows 1-3 of 3

  • GensuPen 2 Ref PEN.A4.003.16

    Class IIb
    Active CE MDD EUDAMED IIb
  • GensuPen 2 Ref PEN.A4.002.16

    Class IIb
    Active CE MDD EUDAMED IIb
  • GensuPen 2 Ref PEN.A4.004.16

    Class IIb
    Active CE MDD EUDAMED IIb

Company details

EUDAMED SRN
PL-MF-000030862
EU VAT number
PL5210082573
EUDAMED status
Active
EUDAMED registered name
Bioton S.A.
EUDAMED abbreviated name
Bioton S.A.
Registered address
12, Poznańska, 05-850, Ożarów Mazowiecki, Poland
Phone
+48 22 721 40 00
PRRC contact
Rafał German(public in EUDAMED)

From the company website

Read 18 Sep 2026

BIOTON is a Polish modern biotechnology company, providing patients with safe and comprehensive solutions for the treatment of diabetes.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does Bioton S.A. have in the registry?

The registry currently lists 3 devices for Bioton S.A.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioton S.A.'s devices?

Among its 3 most recently registered devices, Bioton S.A. has devices listed in EUDAMED (3 devices).

What risk classes do Bioton S.A.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Bioton S.A.'s devices are Class IIb. Each device page shows its own class and authorisation.

What are the newest devices from Bioton S.A. in the registry?

The most recently registered devices listed for Bioton S.A. include GensuPen 2.

Generated automatically from registry data and not verified by a human reviewer.