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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)

Failid

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
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