Future European Authorised Representative - kind request

Dokumendiregister Ravimiamet
Viit MSO-8/57-1
Registreeritud 07.01.2025
Sünkroonitud 08.01.2025
Liik Sissetulev kiri
Funktsioon MSO Meditsiiniseadmed
Sari MSO-8 Turujärelevalvega seotud nõustamine
Toimik MSO-8/2025
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat Indaea OÜ
Saabumis/saatmisviis Indaea OÜ
Vastutaja Egle Audova (RA, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

Future European Authorised Representative - kind request.msg
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From: Irena Milobratovic <irena@indaea.co>
Sent: Thu, 02 Jan 2025 19:33:35 +0000
To: "mso@ravimiamet.ee" <mso@ravimiamet.ee>
Subject: Future European Authorised Representative - kind request

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.


 
Dear Colleagues,

I hope my email finds you well!

My name is Irena Milobratovic and I am the owner of the company Indaea (Registration Number: 17019274) & Principal Consultant. 

I will be representing the client from the US as a European Authorised Representative in the EU.  
Thus, as an Estonian company, I would like to check with you if there is a national procedure/notification step to the Estonian NCA.

If this is the case, could you please guide me on local requirements and on how to perform this step?
The Device is Class I, an antibacterial herbal dental oral solution.

Thank you so much for your support, and all the best,
Irena

I wish you a joyful, healthy, and prosperous New Year!


Irena Milobratovic, MPharm, RAC EU
CEO & Principal Consultant

Email: irena@indaea.co
Phone: +38766901641

We Create. Advise. Rethink. Evolve. Join us!


Indaea
Telliskivi 57/1
10412 Tallinn
Estonia
Email: hello@indaea.co
Phone: +3726028462

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Nimi K.p. Δ Viit Tüüp Org Osapooled
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Vastus päringule 13.01.2025 1 MSO-8/57-3 Sissetulev kiri ra Indaea OÜ
Future European Authorised Representative - kind request 07.01.2025 1 MSO-8/57-2 Väljaminev kiri ra Indaea OÜ