| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/11566-1 |
| Registreeritud | 13.11.2024 |
| Sünkroonitud | 14.11.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
| Toimik | 11.1-2/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | ClaroNav Inc |
| Saabumis/saatmisviis | ClaroNav Inc |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Carly Desmond <[email protected]>
Sent: Thu, 01 Jun 2023 17:49:08 +0000
To: "[email protected]" <[email protected]>
Cc: Tom Tilmans <[email protected]>
Hello,
My name is Carly Desmond. I am the Director of Regulatory Affairs for ClaroNav Inc.
ClaroNav manufactures a Dental Navigation system called Navident, which is CE-marked in accordance with the MDD, and following the transitional arrangements of the EU MDR.
We have a interested customer in Estonia and would like to confirm that we are meeting all requirements to sell in the country.
In addition to holding a valid EC Certificate, my understanding is that we must submit a notification to TEHIK within 10 days of distribution. Are we able to submit the notification directly? Are there any other requirements?
Best regards,
Carly Desmond
Director of Regulatory Affairs
Phone: +1-437-339-6856
E-mail: [email protected]
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.