Saatja: Balti Intermed OÜ - Finants <
[email protected]>
Saaja: RA MSO
Teema: Küsimus registreerimise kohta
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Tere
Firma Steris, USA pöördus meie poole alljärgneva küsimusega:
We are working on the Registration assessment for a class IIb medical devices – ADASPOR PLUS M CONCENTRATO
In details, this is classified as “Disinfectant and cold chemical sterilant for invasive and non-invasive medical devices”.
This device is not yet compliant to MDR, but we would ask your support in order to know the registration requirements for selling the product in Estonia.
Could you please confirm if the registration is required for class IIb Medical Device according with the EU MDR requirements?
Kas te saaksitye meid selle vastusega aidata?
Lugupidamisega,
Edeli Mardiste
60 14 142
BaltiIntermed
Balti Intermed OÜ
Tartu mnt. 84D, Tallinn 10112, Estonia
www.intermed.ee <http://www.intermed.ee/>