Sissetulev kiriAvalik
Küsimused
Ravimiamet · 4. juuli 2025
- Viit
- MSO-2/3366-1
- Registreeritud
- 4. juuli 2025
- Dokumendi liik
- Sissetulev kiri
- Adressaat
- SCI Health
- Saabumis/saatmisviis
- e-post
- Funktsioon
- MSO Meditsiiniseadmed
- Sari
- MSO-2 Eesti turule lastavate/kasutusele võetavate/levitatavate seadmete teavitused ning EC sertifikaadid
- Toimik
- MSO-2/2025
- Vastutaja
- Karl Kalev Türk (RA, Meditsiiniseadmete osakond)
Sisu (failidest)
Saatja: Goda Grybauskaitė <[email protected]>
Saaja: RA MSO
Teema: 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 <https://www.scihealth.eu/> . We are interested in placing our UV phototherapy medical device UV Tactus <https://www.uvtactus.eu/en/> in Estonia. In your web page it states, that we need to submit a notification through the online Estonian Medical Devices and Appliances Database <https://msa.sm.ee/ctrl/en/Avaleht/index/?> (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.
--
Kind Regards
Goda Grybauskaitė
Quality Specialist
SCI Health
Ateities st. 10, Vilnius, LT-08303, Lithuania