Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/11711-1 |
| 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 | Ottobock Scandinavia AB |
| Saabumis/saatmisviis | Ottobock Scandinavia AB |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Fridh, Pernilla" <[email protected]>
Sent: Thu, 20 Apr 2023 06:54:42 +0000
To: "[email protected]" <[email protected]>
Cc: "Priha; Joni" <[email protected]>
Subject: Register as a distributor of medical devices
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Good Morning,
Ottobock Scandinavia AB, which is a legal company registered in Sweden, are planning to start market a medical device from the brand Exopulse in Estonia.
Before doing do, where do we register this with the authorities and information do you need?
The product is CE-marked and have the necessary technical documentation.
I have looked into your website but not been able to find a registration form,
Thank you in advance,
Hälsningar/Kind Regards
Pernilla Fridh
QEHS & RA Specialist
Ottobock
Greater Nordic Region
Box 4041 | SE-169 04 Solna | Barks väg 7 | Sweden
Phone: +46 (0)722 023456
[email protected] | ottobock.se
