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Roko Sp. Z O.O.

Active in EUDAMED

Polandfrom SRN EUDAMED SRN PL-MF-000050171

Devices
127
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Roko Sp. Z O.O. makes

ROKO SP. Z O.O. manufactures dental and orthodontic materials, including dental impression materials (e.g., Dentiflex DCM, Dentiflex DLL, Dentiflex DRS) and orthodontic wax (e.g., Vitaplex VR 250g, Vitaplex VN 250g). The company also produces dental adhesives and bonding agents (e.g., Acron ATL, Acron ASS) and dental cement bases (e.g., Biocetal C4 500g, Biocetal C2L).

All listed devices fall under Class I medical device classification and are registered in the EUDAMED database. The company is based in Poland.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
PL-MF-000050171
EU VAT number
PL5732916244
EUDAMED status
Active
EUDAMED registered name
ROKO SP. Z O.O.
EUDAMED abbreviated name
ROKO
Registered address
177, Bór, 42-200, CZĘSTOCHOWA, Poland
Phone
+48 343697821
PRRC contact
MAREK ROKOSA(public in EUDAMED)

From the company website

Read 18 Oct 2026

The technical facilities of ROKO allow repair of our products up to 24 hours from their reception to the service. If repair is impossible within this time limit, we provide a replacement device.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does ROKO SP. Z O.O. have in the registry?

The registry currently lists 127 devices for ROKO SP. Z O.O.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ROKO SP. Z O.O.'s devices?

Among its 50 most recently registered devices, ROKO SP. Z O.O. has devices listed in EUDAMED (50 devices).

What risk classes do ROKO SP. Z O.O.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for ROKO SP. Z O.O.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from ROKO SP. Z O.O. in the registry?

The most recently registered devices listed for ROKO SP. Z O.O. include Dentiflex DCM, Biocetal C4 500g, Biocetal C2L and Vitaplex VR 250g.

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