| Dokumendiregister | Ravimiamet |
| Viit | MSO-2/3366-1 |
| Registreeritud | 04.07.2025 |
| Sünkroonitud | 07.07.2025 |
| Liik | Sissetulev kiri |
| Funktsioon | MSO Meditsiiniseadmed |
| Sari | MSO-2 Eesti turule lastavate/kasutusele võetavate/levitatavate seadmete teavitused ning EC sertifikaadid |
| Toimik | MSO-2/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | SCI Health |
| Saabumis/saatmisviis | SCI Health |
| Vastutaja | Karl Kalev Türk (RA, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Goda Grybauskaitė <[email protected]>
Sent: Fri, 13 Jun 2025 08:53:36 +0000
To: <[email protected]>
Subject: Placing a Medical Device on the Estonian Market
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
My name is Goda Grybauskaitė. I work in a Lithuanian start-up
type company
SCI Health. We are interested in placing our UV
phototherapy medical device UV Tactus in Estonia. In your
web page it states, that we need to submit a notification
through the online Estonian Medical Devices and Appliances
Database (EMDDB). To place the notification we
need to login, however we do not have an account. Is it possible
to make one?
Our medical device UV Tactus is a Class II medical device, and
it is CE-certified. Our company is also ISO 13485 certified.
Thank You for your time and I look forward to your response.